Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077458
Company: HIKMA

Products on ANDA 077458

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077458

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.

Therapeutic Equivalents for ANDA 077458

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