Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074488
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription AB No No
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/31/1997 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/30/2007 SUPPL-22 Labeling

Label is not available on this site.

08/01/2003 SUPPL-19 Labeling

Label is not available on this site.

05/22/2001 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

03/19/2003 SUPPL-17 Labeling

Label is not available on this site.

12/13/2001 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/13/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/2001 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

12/13/2001 SUPPL-13 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

09/11/2000 SUPPL-12 Labeling

Label is not available on this site.

04/06/2000 SUPPL-11 Labeling

Label is not available on this site.

04/06/2000 SUPPL-10 Labeling

Label is not available on this site.

06/07/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/14/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/30/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/30/2000 SUPPL-5 Labeling

Label is not available on this site.

08/30/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/30/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/15/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

RANITIDINE HYDROCHLORIDE

TABLET;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 203694 ACIC PHARMS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 077824 AMNEAL PHARMS NY
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 074488 ANI PHARMS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 074680 APOTEX
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 076705 DR REDDYS LABS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 078542 GLENMARK PHARMS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 075165 HERITAGE PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 075180 PAR PHARM
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 074467 SANDOZ
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 205512 STRIDES PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 210010 STRIDES PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 211289 VKT PHARMA PVT LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 075208 WOCKHARDT LTD

TABLET;ORAL; EQ 300MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 203694 ACIC PHARMS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 077824 AMNEAL PHARMS NY
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 074488 ANI PHARMS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 074680 APOTEX
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 076705 DR REDDYS LABS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 078542 GLENMARK PHARMS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 075165 HERITAGE PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 075180 PAR PHARM
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 074467 SANDOZ
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 205512 STRIDES PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 210010 STRIDES PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 211289 VKT PHARMA PVT LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 075208 WOCKHARDT LTD

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