Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075611
Company: APOTEX

Products on ANDA 075611

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Discontinued	None	No	No
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075611

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/23/2001	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75611_Famotidine_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75611_Famotidine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075611_famotidine_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2020	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/12/2020	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/16/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/21/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 075611

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/23/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75611_Famotidine_Prntlbl.pdf