Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074664
Company: PAI HOLDINGS PHARM

Products on ANDA 074664

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIMETIDINE HYDROCHLORIDE	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074664

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/1997	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/074664_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074664.PDF

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/13/2019	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 074664

CIMETIDINE HYDROCHLORIDE

SOLUTION;ORAL; EQ 300MG BASE/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIMETIDINE HYDROCHLORIDE	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	074251	CHARTWELL MOLECULAR
CIMETIDINE HYDROCHLORIDE	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	074664	PAI HOLDINGS PHARM