Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074777
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription AP 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
03/02/2005 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
01/28/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

06/18/2009 SUPPL-4 Labeling

Label is not available on this site.

02/15/2006 SUPPL-2 Labeling

Label is not available on this site.

RANITIDINE HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 25MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription No AP 079076 MYLAN LABS LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074777 WEST-WARD PHARMS INT
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077458 WEST-WARD PHARMS INT
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription No AP 091534 ZYDUS PHARMS USA INC
ZANTAC RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019090 TELIGENT

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