Available CTD Dossier List | Common Technical Dossier (CTD) Database

Sr. No	Product Name	Strength	BE Study	Region
1	Acetylsalicylic acid 100 mg / Atorvastatin 20 mg / Ramipril 2.5/5/10 mg	HardCapsule	Avilable	GCC
2	Aciclovir powder for soln for infusion	500, 250 mg	Reference data	EU
3	Acyclovir ointment 5 % USP	5 %	Reference data	US
4	Albumin Macro Aggregated inj	10ml		TGA
5	Alfacalcidol soft gel capsules	1, 0.5, 0.25 micro	Avilable	EU
6	Alfuzosin Prolonged release	10mg
7	Alizapride hydrochloride 50 mg	2ml Ampule	Reference Data	GCC
8	Allopurinol 200 mg tablets	200 mg tablets	Available	EU
9	Amantadine Hydrochloride Capsules USP,	100 mg	Available	US
10	Ambroxol Hcl Effervecent Tablet	60 mg	Reference data	EU
11	Amlodipine & Valsartan Tablets	10/320 mg, 5/320, 10/160, 5/160, 5/80, 5/160.	Available	US
12	Amlodipine 5mg 10mg Tablets	5mg 10mg Tablets	Available	EU
13	Amoxicillin Clavulanate Powder for inj	500 mg 100mg inj, 1000 mg 200mg inj	Reference data	EU
14	Amoxicillin clavulanic acid potassium	Tablet
15	Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Black current	Lozenges	Reference Data	EU
16	Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Honeylemon	Lozenges	Reference Data	EU
17	Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Lemon	Lozenges	Reference Data	EU
18	Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Orange	Lozenges	Reference Data	EU
19	Anastrozole Film Coated Tablet	1mg	Avilable	EU
20	Apixaban Tablet 2.5, 5mg	2.5, 5mg
21	Argatroban 100 mg/ml infusion	100 mg/ml infu	Reference data	EU
22	Aripiprazole 10 mg	5 mg, 10 mg, 15, 20, 30 mg Tablet	Avialable	EU
23	Aripiprazole 1mg/ml oral solution			EU
24	Asenapine Sublingul Tablets	10 mg 5mg.	Available	US
25	Atenolol BP Tablet	100mg	Reference Data	Malaysia
26	Atorvastatin tablet	20 mg	Avilable	Ethiopia
27	Atovaquone & Proguanil HCl Film-Coated Tablets	62.5mg/25mg & 250mg/100mg FCT	Module 2, 3
28	Azithromycin 250mg Capsule	250mg Capsule	Reference Data	EU
29	Azithromycin Dispersible tablet	100 mg		Uganda
30	Baclofen Injection	0.05 mg, 0.5mg, 1 mg 2 mg 3 mg/ ml	Reference Data	EU
31	Beclometasone nasal Spray	50 mic	Reference data	EU
32	Bendamustine Hcl 2.5 mg/ml Powder for Injection	2.5 mg/ml (100 mg/vial)	Reference Data	EU
33	Benfotiamine	300 mg film-coated tablet	Not Applicable	EU
34	Betahistine Tablet	16 mg, 8mg	Avilable	GCC
35	Betaxolol hydrochloridum Tablet	20 mg Tablet	Available	EU
36	Bicalutamide 150mg FCT	150 mg, 50mg	Avilable	EU
37	Bisoprolol Tablet	Tablet	Available	EU
38	Bosentan FCT	125 mg, 62.5 mg	Avilable	EU
39	Botulinum Toxin Type A Lyopilized	50 U, 100 U Soln for inj	Available	EU
40	Brintellix Film-coated tablets	5 mg, 1 0 mg, 15 mg and 20 mg FCT	Available	EU
41	Buccal Oral Insulin Spray	Inhalation	Reference Data	GCC
42	Budesonide Entric coated Tablet	3 mg	Avilable	US
43	Bupivacaine Solution for Injection	2.5 mg/ml, 5 mg/ml Injection
44	Buprenorphine Patches	5mcg/h 10mcg/h	Available	EU
45	Buprenorphine Hcl + Naloxone Hcl Sublingual	8mh/2mg, 2mg/0.5mg Tablet	Avilable	US
46	Bupropion Tablets USP	100 mg, 75mg	Available	EU
47	Bupropion Tablets USP (Modified Delayed Release)	300 mg, 150 mg	Available	US
48	Buspirone hydrochloride	5 mg, 10mg	Reference data	EU
49	Calcium folinate Powder Soln for Inj	200 Mg, 100mg	Avilable	EU
50	Calcium Levofolinate Soln for Inj	10 mg/ml	Reference data	EU
51	Candesartan Cilexetil & Hydrochlorothiazide	32/25 mg, 32/12.5 mg,	Available	EU
52	Candesartan Cilexetil Tablets	32 mg, 16mg, 8mg, 4mg	Available	CA
53	Capecitabine Film-coated Tablets	500mg, 300mg, 100 mg	Avilable	EU
54	Capsicum 0.05% cream	0.05% cream	Reference Data	EU
55	Carbamazepine USP 200mg Tablet	200mg Tablet	Avilable	US
56	Carboxyl Nethyl Celulose Eye Drops	0.5 w/v		Mosambique
57	Carvidelol Tablet	12.5 mg , 25mg	Avilable	EU
58	Caspofungin Acetate powder sol for inf	70 mg, 50mg	Reference Data	EU
59	Cefazolin Injection	2 G, 1G	Reference Data	EU
60	Cefepime Hcl injection	1G, 2G Vail	Reference Data	EU
61	Cefotaxime injection	0.5G, 1G, 2G vail	Reference Data	EU
62	Ceftazidime inj	0.5, 1, 2g.		EU
63	Ceftriaxone 1G powder for Injection	2G, 1G, 500mg Injection	Reference data	EU
64	Celecoxib cap	200 mg, 100 mg	Available	EU
65	Celecoxib Cap	200mg	Available	US
66	Celecoxib capsule	200mg	Avilable	GCC
67	CETIRIZINE 1mg/ml ORAL SOLUTION	1mg/ml ORAL SOLUTION	Reference Data	EU
68	Cetirizine Dihydrochloride	10 mg Tablets	Avilable	EU
69	Chlorohexidine, Benzocaine lozenges	5 mg/5mg	Reference data	EU
70	Chlorohexidine, Benzocaine Strong lozenges	5mg/5mg	Reference data	EU
71	Chlorthalidone USP 25 mg Tablet	50mg,25 mg Tablet	Avilable	US
72	Cholecalciferol oral drops solution	10,000 IU/ml, 25,000 IU/2.5 ml oral solution oral drops solution	Reference Data	EU
73	Cilnidipine Tablets	5mg	Reference Data	Jordan
74	Cilnidipine Tablets 5 mg	5mg Tablets		Philippines
75	Cinacalcet Hydrochloride Tablets	90 mg, 60 mg, 30 mg	Avilable	US
76	Ciprofloxacin tablets USP	250 mg, 500mg		Uganda
77	Cisatracurium soln for inj/inf	20mg, 10mg, 5mg, 1mg/ml	Reference data	EU
78	Citalopram 10mg, 20mg & 40mg Tablets	10mg, 20mg & 40mg Tablets	Avilable	EU
79	Cladribine	1mg/ml	Reference data	EU
80	Clarithromycin HEC	500 mg	Avilable	EU
81	Clopidrogrel Tablet USP	75mg	Avilable	US
82	Colecalciferol 800 IU soft Cap	800 IU soft Cap	Reference data	EU
83	Colestyramine light powder	4g oral suspension	Available	EU
84	Cyamemazine 100mg 25 mg tablet	100mg 25 mg Tablet	Avilable	EU
85	Cyclofosfamide Sol for Injection	2g, 1g, 500 mg	Reference data	EU
86	Cytarabine 20 mgml	20 mg ml	Reference data	EU
87	DAP-Penicillin powder sol for inj	0.4mg/0.5mg	Reference data	EU
88	Desflurane 100% Volatile liq for Inh.	Inhalation		EU
89	Desloratadine- Film-coated Tablets	5 mg	Avilable	EU
90	Desogestrel and Ethinylestradiol tablets	150 micrograms and 20 micrograms	Available	EU
91	Desogestrel FCT	750 mcg	Available	EU
92	Desvenlafaxine Extended-Release Tablets	100 mg, 50mg	Available	US
93	Dexamethasone 4mg/ml	4mg/ml	Reference data	EU
94	Dexketoprofen Injection	50 mg/2ml	Reference Data	EU
95	Dextromethorphan hydrobromide monohydrate	15 mg and 30 mg tablets	Avilable	EU
96	Diazepam 5 mg tablet	5 mg tablet	Avilable	EU
97	Diazepam 5 mg/ml solution for injection	5 mg/ml solution for injection	Reference Data	EU
98	Diclofenac Eye Drop 1mg/ml Singe use 0.5ml		Reference Data	EU
99	Diclofenac Sodium Gel	1% gel	Reference Data	Myanmar
100	Diclofenac Sodium injection	25 mg/ml	Reference Data	Belarus
101	dienogest 2.0 mg/ estradiol valerate 1.0 mgFCT	2.0 mg/1.0 mg FCT	Available	EU
102	DIGEODREN Granules	Granules	Reference Data	EU
103	Dipyridamol Modified release Cap Hard	200 mg	Avilable	EU
104	Disodium pamidronate inj	90mg, 60mg 30 mg	Referece Data	EU
105	Docetaxel 20 mg/ml	20 mg/ml	Reference data	EU
106	Donepezil hydrochloride Tablet	10 mg, 5mg	Avilable	CA
107	Drospirenone 3.0 mg/Ethinylestradiol 0.020mgFCT	3.0 mg/ 0.020 mg Film-coated tablets, 3.0 mg/ 0.030 mg	Avialable	EU
108	Duloxetine HCl DR Cap	60 mg, 40, 30, 20, mg	Available	EU
109	Duloxetine hcl Gastro resistant cap	60 mg, 30 mg		EU
110	DUTASTERIDE 0.5 mg SOFT CAPSULES	0.5mg Soft Cap	Available	EU
111	Dutasteride soft capsules	0.5mg	Avilable	EU
112	Efavirenz Film coated Tab	600mg Fct	Avilable	EU
113	Emitricitabine and Tenofovir disoproxil	200mg/245mg Tablet	Available	EU
114	Enoxaparin	150, 100 mg/ml	Avilable	EU
115	Enoxaparine	300 mg/3ml	Avilable	EU
116	Enoxaperine 6K 8K 10K, 4k,2k	10,000 IU	Reference data	EU
117	Epirubicin hydrochloride	2 mg/ml solution for injection	Reference Data	EU
118	Eplerenone Film Coated Tablet	50 mg 25mg	Avilable	EU
119	Eptifibatide solution	2mg/ml, 0.75mg/ml	Reference data	EU
120	Erlotinib FCT	150 mg, 100mg, 25mg	Reference data	EU
121	Ertapenem Injection	1G injection	Reference	EU
122	Escitalopram film coated Tablets	20, 15, 10, 5 mg	Avilable	EU
123	Esomeprazole Powder for sol inj/infu	40 mg	Reference data	EU
124	Etoposide 20 mg/ml	20 mg/ml	Reference data	EU
125	Etoricoxib film-coated tablets	120mg, 90, 60, 30 mg	Avilable	EU
126	Etoricoxib film-coated tablets*	60, 90, 120 mg*	Avilable	EU*
127	Everolimus 2.5 mg, 5 mg 10mg tablets		Available	EU
128	Exemestane FCT	25 mg	Avilable	EU
129	FAMCICLOVIR FILM-COATED TABLETS	TABLETS 125mg/250mg/500mg/750mg	Avilable	EU
130	Famotidine USP Tablets	40 mg, 20mg		US
131	Febuxostat Tablet	120 mg , 60mg	Available	EU
132	Fenofibrate Tablets, 54 160 mg USP	54 and 160 mg Tablets	Available	US
133	Fenofibric Acid Capsule 135mg	135 mg capsule	Reference	EU
134	Fenofibric acid DR cap USP	135 mg, 45mg	Available	US
135	Fingolimod cap	0.5 mg	Available	EU
136	Flucloxacillin Powder for Solution for Injection	250 mg, 500mg, 1000 mg Injection	Reference Data	EU
137	Fluconazole infusion	100 mg per vail	Referece Data	EU
138	Fluconazole injection		Reference Data	Ethiopia
139	Fluconazole soln for injection	100mg /50ml	Reference Data	EU
140	Flumazenil 0.1mgmL Solution	0.1mg/mL	Reference data	EU
141	Fluorouracil Solution for Injection	50 mg/ml	Reference data	EU
142	Fluoxetine capsule Hard	20 mg	Reference data	EU
143	Fluoxetine Tablets USP	30 mg, 10mg	Available	US
144	Fluticasone Propionate & Salmeterol CFC Free Inhaler	250/25 mic	Avilable	EU
145	Fosfomycin Trometamol 3 g granules	3 G oral solution	Reference Data	EU
146	Gabapentine 100mg cap	400mg, 300mg, 100mg cap	Avilable	EU
147	Gadopentetate Dimeglumine injection		Reference Data	Malaysia
148	Galantamine 4mg/ml oral solution.	4mg/ml	Reference Data	EU
149	Ganciclovir 500mg	500mg	Reference data	EU
150	Geftinib FCT	250 mg FCT	Avilable	EU
151	Gemcitabine 10 mgml	10 mg/ml	Reference data	EU
152	Gemifloxacin 320 mg FCT	320 mg FCT	Avilable	GCC
153	Gliclazid sustain release	30mg	Avilable	EU
154	HeliCap 37 kBq, capsules	37 kBq Capsule	Clinical Report	EU
155	Heparin Solution for injection	5000 UI ml	Refeference data	EU
156	Hydrocortisone powder for solution	250 mg, 100mg	Reference Data	EU
157	Ibandronic Acid 3mg3ml	3mg/3ml	Reference data	EU
158	Ibuprofen chewable soft gelatin capsules	100 mg 50 mg Soft Gel chewable	Available	EU
159	Ibuprofen Solution for Infusion	600mg/ 100ml	Reference data	EU
160	Ibuprofen 200 mg oral suspension Sachet	200 mg, 400mg	Avilable	EU
161	Ibuprofen 400 mg FCT Tablets	400 mg FCT, 600mg	Avilable	EU
162	Ibuprofen Lysine 342 mgFCT	684mg, 342 mg FCT	Available	EU
163	Ibuprofen Solution for Infusion	400mg/100ml	Reference data	EU
164	Ibuprofen/Paracetamol 200 mg/325 mg tablets	200 mg/325 mg tablets	Reference Data	EU
165	Imatinib Capsule	400 mg, 100 mg	Avilable	EU
166	Imatinib Tablet 100mg 400mg	100mg 400mg	Avilable	EU
167	Imipenem + Cilastatin Powder for Sol	500mg+ 500mg, 250mg + 250 mg	Reference data	EU
168	Iodixanol 320 mg I/ml Solution for injection		Reference Data	EU
169	Iohexol Intravenous 300	Contras Media
170	Iopamidol Injection USP	300 370 mg	Reference Data	EU
171	Irbesartan Film Coated Tablet	300 mg, 150mg, 75mg	Avilable	EU
172	Irinotecan Hcl trihydrate Infusion	100mg/5ml	Reference data	EU
173	Irinotecan Hcl trihydrate Infusion	40mg/2ml	Reference data	EU
174	Irinotecan Hcl trihydrate Infusion	20mg/ml	Reference data	EU
175	ISMIGEN 50mg Sublingual Tablet		Available	GCC
176	Itraconazole Capsules	100 mg	Available	US
177	Ketamine hydrochloride Inj	50 mg/ml
178	Ketorolac Trometamol 10 mg/ml Solution for Injection	10 mg/mL	Reference Data	EU
179	Lacidipine FCT	2mg, 4mg, 6mg FCT	Available	EU
180	Lamivudine Tablet	150mg	Avilable	US
181	Lamoterigine extended release tablet	50 mg	Avilable	EU
182	Lamotrigine Tablets USP	200 mg, 150mg, 100mg, 25mg	Available	US
183	Lefunomide Tablets USP	20 mg, 10mg	Available	US
184	Letrozole film coated	2.5mg	Avilable	EU
185	Levetiracetam Tablets	1000mg, 750mg, 500mg,250mg	Avilable	EU
186	Levobupivacaine soln for infusion	1.25 mg/ml	Reference data	EU
187	Levobupivacaine soln for infusion	7.5, 5, 2.5, 0.625 mg/ml	Reference data	EU
188	Levodopa/Carbidopa/Entacapone FCT	50+12.5+200 , 100+25+200, 150+37.5+200, 200+50+200 mg	Avilable	EU
189	Levofloxacin 5mg/ml soln for infu.	5mg/ml	Reference data	EU
190	Levofloxacin Film Coated Tablet	500 mg, 250 mg	Avilable	EU
191	Levonorgestrel Tablet 1.5mg	1.5 mg Tablet	Available	EU
192	Lidocaine 10mg/ml soln for infu.	50mg, 20 mg, 10mg/ml	Reference data	EU
193	Linezolid film tablet	600 mg	Reference data	EU
194	Linezolid sol for inj	2mg/ml	Reference data	EU
195	Linezolid Tablet	600 mg	Available	EU
196	Losartan Potassium & Hydrochlorothiazide Tablets USP	100/25 mg, 100/12.5, 50/12.5 mg	Available	US
197	Macrogol powder for oral solution	6.86 g/13.72 g	Reference data	EU
198	Megestrol acetate oral solution	40mg/ml	Avilable	EU
199	Memantine film-coated tablets	20mg, 10 mg	Reference data	EU
200	Memantine HCl Tablets USP	20 mg, 10 mg	Available	US
201	Meprobamate Tablets USP	400 mg, 200 mg	Reference Data	US
202	Meropenem powder for Sol	1000 mg Inj, 500 mg	Reference data	EU
203	Metformin FCT	1000mg, 850 mg, 500 mg	Avilable	EU
204	Methotrexate Oral Soln	2mg/ml Oral Solutin	Avilable	EU
205	Methylprednisolone powder sol for inj	125mg, 40mg	Reference data	EU
206	Metoprolol tartrate 100mg 50mg Tablet	100 mg 50mg tablet	Available	EU
207	Metoprolol tartrate SR 200 mg	200mg SR Tablet	Avilable	EU
208	Metoprolol tratarate & Hydrochlorothiazide	100/50 mg, 100/25, 50/25 mg	Available	EU
209	Metronidazole Gel		Reference Data	Ethiopia
210	Metronidazole 5 mg/ml Solution for Infusion	5 mg/ml Solution for Infusion	Module 1 2 3	EU
211	Metronidazole Capsule USP	375 mg	Available	US
212	Metronidazole Dental Gel		Reference Data	Ethiopia
213	Metronidazole Tablets USP	500 mg, 250 mg	Available	US
214	Metronidazole-gel	Gel		Ethiopia
215	Mitomycin Solution for Injection	40mg/ml	Reference data	EU
216	Mitoxantrone Concentrate Sol for Infu	2 mg/ml	Reference data	EU
217	Mitoxantrone hydrochloride Conc Sol inj	2 mg/ml	Reference data	EU
218	Modafinil Tablets USP	200mg, 100 mg	Available	US
219	Montelukast	10 mg tablet	Avilable	US
220	Montelukast Sodium Chewable tab	10 mg		Tanzania
221	Moxifloxacin FCT	400mg	Avilable	GCC
222	Mycophenolic Acid Tablets	360 mg	Avilable	US
223	Nebivolol Tablets	20 mg, 10mg, 5mg, 2.5 mg	Reference Data	Mayanmar
224	Nicorandil Tablet	20mg, 10mg	Avilable	EU
225	Nicotin Chewing gum
226	Nisoldipine ER Tablets	34 mg, 25mg, 17.5mg,8.5mg	Available	US
227	Nitisinone Capsule	2mg, 5mg, 10mg cap	Avilable (M1 M3 M5)	US
228	Ofloxacin eye drops, solution	3mg/ml	Reference data	EU
229	Ofloxacin 0.5 ml single dose	0.5 ml	Reference data	EU
230	Olanzapine Film Coated Tablet	10 mg, 5mg	Avilable	EU
231	Olmesartan & Hydrochlorothiazide Tablets	40/25 mg, 40/12.5, 20/25, 20/12.5 mg	Available	US
232	Olmesartan Medoxomil Tablets	40 mg, 20mg, 10mg	Available	EU
233	Olopatadine Ophthalmic solution USP 0.1 %	0.1 %	Refercee Data	US
234	Omega-3-Acid Ethyl Esters 90 Momaja 1000mg Soft Gel Capsules	1000mg	Avilable	EU
235	Omeprazol Capsule	40mg, 20mg,10 mg	Avilable	EU
236	Omeprazole powder for soln for inf	40 mg	Reference Data	EU
237	Ondansetron hcl dehydrate Sol for Inj	8mg/4 ml	Reference Data	EU
238	Ondansetron hcl dehydrate Sol for Inj	4 mg/2 ml	Reference Dta	EU
239	Orlistat capsules	120 mg	Available	EU
240	Ornidazole-Injection	500mg / 100ml Injection		Ethiopia
241	Oxaliplatin Powder for Sol for Inf	5 mg/ml	Reference data	EU
242	Oxycodone Hcl + Naloxone Hcl Prolonged release Tablet	5/2.5, 10/5, 20/10, 30/15, 40/20 mg	Avilable	EU
243	Paclitaxel Infusion	30 mg/5 ml; 100 mg/16.7 ml; 150 mg/25 ml; 300 mg/50 ml
244	Palonosetron Hcl 250 micro soln for inj	250 micro gram	Reference data	EU
245	Pamidronate disodium	3 mg/ml	Reference data	EU
246	Pantoprazole gastro-resistant tablets	20 mg 40 mg Tablets	Available	EU
247	Pantoprazole Powder injection	40mg	Reference data	EU
248	Paracetamol 500mg tablet	500mg	Reference data	EU
249	Paracetamol , CPM, phenylephrine & caffine	500/2/25/30		Tajikistan
250	Paracetamol IV Injection	10 mg/ml	Reference Data	Myanmar
251	Paracetamol Tablet	1000mg	Avilable	EU
52	Paricalcitol 2 microgram/ml injection	5 microgram/ml, 2 microgram/ml	Reference data	EU
253	Paroxetine Hcl Extended release Tablet	37.5 mg, 25mg, 12.5g	Avilable	EU
254	Phloroglucinol 40 mg /4 ml Solution	40mg/4 ml soution for injection	Reference Data	EU
255	Phloroglucinol 80 mg Orodispersible Tablets	80 mg Orodispersible Tablets	Biowaver	EU
256	Pioglitazone Hcl USP Tablet	15, 30, 45 mg immediate release oral tablets.	Available	US
257	Piperacillin + Tazobactam 2G/0.25 g Powder for soln	4g/0.50g, 2g/0.25g	Reference data	EU
258	Polyvalent Mechanical Bacterial Lysate (PMBL)	50 mg Tablets	Reference Data	GCC
259	Pramipexole Tablet	0.18, 0.70, 0.35, 0.7, 0.18, 0.088 mg	Reference data	EU
260	Pramipexole Dihydrochloride Extended-Release Tablets	4.5 , 3.75, 3, 2.25, 1.5, 0.75, 0.375 mg	Available	EU
261	Pramipexole Prolonged release Tablets	3.15, 2.62, 2.1, 1.57, 1.05, 0.52, 0.26mg	Available	US
262	Pregabaline hard capsule	300, 225, 200, 150, 100, 75, 50, 25 mg	Available	EU
263	Purified gamma globulin (IgG) antibodies to Rho (D) antigen.	3 , 6 20 ml Vail	Reference Data	GCC
264	Quetiapine FCT	300mg, 200mg, 150mg, 100 mg, 25mg	Avilable	EU
265	Quetiapine Prolonged Release Tablets	50 mg, 150 mg, 200 mg, 300 mg and 400 mg	Avilable	EU
266	Ramipril Tablets	10mg, 5mg, 2.5mg, 1.25 mg	Avilable	EU
267	Rasagiline 1 mg tablets	1 mg	Avilable	EU
268	Rebeprazole delayed release
269	Remefentanil 1mg/ml powder for inj	5, 2, 1mg/ml for inj	Reference data	EU
270	Resperidone Tablet
271	Riluzole 5 mg/ml oral suspension	5 mg/ml oral suspension	Available	EU
272	Risedronate Sodium Tablets	35 mg	Avilable	US
273	Risperidone USP Tablet	4, 3, 2, 1, 0.5, 0.25 mg	Avilable	US
274	Rivaroxaban Tablets	10 mg	Available	US
275	Rocuronium Solution for Injection	10 mg/ml	Reference data	EU
276	Ropinirol Hcl Prolonged Release	8mg, 6mg, 4mg,3mg,2mg Tablet	Avilable	EU
277	Rosuvastatin Calcium Tabelts	40 mg, 20mg, 10mg, 5mg	Avilable	US
278	Sevelamer carbonate 800 mg FCT	800 mg FCT	Avilable	EU
279	SevofluraneCadiasun 100% Inhal vap liq		Reference data	EU
280	Sildenafil film-coated tablets	100 mg, 50mg, 25mg	Avilable	EU
281	Simvastatin FCT
282	Sitagliptin phosphate Tab	25 50, 100 mg tab	Available	US
283	Sodium hyaluronate ophthalmic solution	20, 40 mg Eye Drop	Refernce Data	EU
284	Solifenacin Succinate 5mg 10 mg Tablet		Available	US
285	Stopropbarm tabletes	30mg,15 mg	Reference data	EU
286	Stricil Solution for Injection	50 mg/ml	Reference data	EU
287	Stritarabine Solution	20 mg/ml	Reference data	EU
288	Subunit Keyhole limpet Hemocyanin (KLH)	20mg/ml vail	Reference	EU
289	Tadalafil Tablets		Avilable	US
290	Tadalafil Tablets	25 mg, 20mg, 10mg, 5mg	Available	EU
291	Telmisartan	80mg,40mg, 20mg	Avilable	EU
292	Telmisartan and Amlodipine Tablets	80/10 mg, 80/5, 40/10, 40/5 mg	Available	EU
293	Tenofovir Disoproxil FCT	204mg, 163 mg,123mg FCT	Available	EU
294	Terbinafine Tablet
295	Thiopental 1000 mg powder for inj	1000 mg for inj, 500mg	Reference data	EU
296	Tianeptine Sodium film coated Tablet	12.5mg	Avilable	EU
297	Ticagrelor Tablets 90 mg	90 mg	Available	US
298	Timolol maleate eye drops	0.50% Eye Drop	Reference Data	EU
299	Tobramycin 40 mgml	40 mg/ml	Reference data	EU
300	Tramadol/Paracetamol FCT	37.5mg/325mg	Reference data	EU
301	Trimetazidine modified release tablets	35mg	Avilable	EU
302	Ursodeoxycholic acid	250mg.	Reference data	EU
303	Valsartan	160mg, 80mg, 40 mg	Avilable	EU
304	Valsartan & Hydrochlorothiazide Tab	320/25, 320/12.5, 160/25, 160/12.5, 80/12.5 mg	Avilable	US
305	Vancomycin Hard gelatin cap.	250mg, 125 mg	Reference data	EU
306	Vardenafil Hcl Orally Disintegrated 10 mg Tablet		Available	US
307	Vardinafil Hcl orally Disintegrating Tab	10 mg	Available	US
308	Venlafaxine HCl Extended release cap	225mg,150 mg, 75mg	Available	EU
309	Venovit capsules hard	180 mg	Reference data	EU
310	Vinorelbine infusion	10mg/ml	Reference data	EU
311	Vitamin A palmitate eye ointment	Eye Ointment	Module 3	EU
312	Vitamin D3	50000IU	Reference data
313	Voriconazole powder sol for infu	200 mg	Reference data	EU
314	WET-COMOD, eye drops	Eye Drop	Reference Data	EU
315	Xylometazoline hydrochloride nasal spray solution	1 mg nasal spray solution	Reference Data	EU
316	Zoledronic acid	0.8 mg/ml	Reference data	EU
317	Zoledronic acid	5 mg/100ml	Reference data	EU
318	Zolmitriptan Tablets	5 mg, 2.5 mg	Available	US
319	Zolpidem tartrate 10mg	10 mg Tablet	Available	EU
320	Zonisamide Tablets 100mg	100 mg Tablet	Module 3	EU
	Tacrolimus Capsules 0.5 mg	1mg, 0.5 mg Cap	Reference	CTD
	Iron Sucrose Injection USP 20mg/ml	20mg/ml	Reference	CTD
	Ivabradine Tablets 5mg	5 mg tablet	Reference	CTD
	Pimecrolimus Cream 1% w/w	Cream 1% w/w	Reference	CTD

What is Common Technical Document (CTD) ?

A collection of requirements for a dossier for the registration of medications is known as the Common Technical Document (CTD). The Therapeutic Goods Administration (TGA) approved the CTD in 2004 after the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) formulated it.

The introduction of appropriate review practises in Pharma industry has been made possible by the way CTD has revolutionised the regulatory review processes and led to a standardised electronic submission. For businesses, it has removed the requirement to alter the data before submitting it to the various ICH regulatory bodies.

There are five modules in the CTD. Modules 2, 3, and 4 are meant to be universal for all regions, while Module 1 is region-specific. The CTD became the preferred format for NDAs submitted to the FDA in the United States and the EU in July 2003, and it is now required for new drug applications in Japan and the EU.

What is Dossier?

The information required to support the quality, safety, and effectiveness of a prescription drug is contained in or referred to in a dossier. The supporting data consists of the first dossier, any subsequent dossiers submitted to the TGA that are cited in the application, and any other supporting information submitted after the initial application filing constitute the supporting data.