01 1Apotex Pharmachem
02 1Boehringer Ingelheim GmbH
03 1ChemSource
04 1Corden Pharma Bergamo S.p.A
05 3Fako Ilaçlari A.S. TR 34390 Istanbul
06 1Genpharma
07 1Heumann
08 1Maprimed
09 1NOVOPHARM LTD
10 1Orchev Pharma
11 2Quimica Sintetica
12 2RANBAXY LABORATORIES LIMITED
13 4SMS Pharmaceuticals
14 2Saraca Laboratories Limited
15 1Shasun Chemicals and Drugs Ltd
16 2Solara Active Pharma Sciences
17 2UQUIFA
18 2Wockhardt
19 3Blank
01 1RANITIDINE HCI (FORM-I)
02 1RANITIDINE HCI FORM 1 DRUG SUBSTANCE
03 1RANITIDINE HCL
04 1RANITIDINE HCL FORM 1
05 1RANITIDINE HCL USP
06 10RANITIDINE HYDROCHLORIDE
07 1RANITIDINE HYDROCHLORIDE (CRYSTALLINE FORM 1)
08 1RANITIDINE HYDROCHLORIDE (FORM-II)
09 2RANITIDINE HYDROCHLORIDE FORM I BULK
10 1RANITIDINE HYDROCHLORIDE FORM II
11 5RANITIDINE HYDROCHLORIDE USP
12 1RANITIDINE HYDROCHLORIDE USP (FORM II)
13 1RANITIDINE HYDROCHLORIDE USP (PROCESS -2)
14 1RANITIDINE HYDROCHLORIDE USP (UNIT-VII)
15 1RANITIDINE HYDROCHLORIDE USP FORM 1
16 1RANITIDINE HYDROCHLORIDE USP, FORM 1
17 1RANITIDINE HYDROCHLORIDE, USP (FORM II)
18 1RANITIDINE HYDROCHLORIDE-FORM 1
01 1Argentina
02 2Canada
03 2Germany
04 14India
05 1Italy
06 1Morocco
07 4Spain
08 3Turkey
09 1U.S.A
10 3Blank
01 3Active
02 29Inactive
01 2Complete
02 30Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10989
Submission : 1994-07-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10885
Submission : 1994-04-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25851
Submission : 2012-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8494
Submission : 1990-03-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10516
Submission : 1993-10-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-11
Pay. Date : 2017-05-31
DMF Number : 31575
Submission : 2017-03-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-15
Pay. Date : 2013-12-09
DMF Number : 8288
Submission : 1989-11-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10273
Submission : 1993-05-27
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8953
Submission : 1991-01-29
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7528
Submission : 1988-06-14
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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