Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075192
Company: MARSAM PHARMS LLC

Products on ANDA 075192

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FAMOTIDINE	FAMOTIDINE	10MG/ML	Injectable; Injection	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075192

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/1998	ORIG-1	Tentative Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75192ta.pdf