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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091534
Company: ZYDUS PHARMS USA INC
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
02/22/2013 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
07/17/2013 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

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 074777 HIKMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 25MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077458 HIKMA
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 PAI HOLDINGS PHARM
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