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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077458
Company: HIKMA
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
02/16/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77458ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/29/2010 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

06/18/2009 SUPPL-1 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 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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