An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	Prescription	AB	No	No
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	AB	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.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2020	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		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

Therapeutic Equivalents for ANDA 075611

FAMOTIDINE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	078916	ALEMBIC PHARMS LTD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	215630	ALKEM LABS LTD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	217375	ALKEM LABS LTD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	215767	ANNORA PHARMA
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	075611	APOTEX
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	215689	ASCENT PHARMS INC
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	206530	AUROBINDO PHARMA LTD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	075805	CARLSBAD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	075786	CHARTWELL RX
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	217669	CONTRACT PHARMACAL
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	075718	DR REDDYS LABS LTD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	218181	GRAVITI PHARMS
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	075511	IVAX SUB TEVA PHARMS
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	075302	MANKIND PHARMA
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Prescription	No	AB	216441	ZYDUS PHARMS

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	078916	ALEMBIC PHARMS LTD
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	215630	ALKEM LABS LTD
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	217375	ALKEM LABS LTD
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	215767	ANNORA PHARMA
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	075611	APOTEX
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	215689	ASCENT PHARMS INC
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	206530	AUROBINDO PHARMA LTD
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	075805	CARLSBAD
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	075786	CHARTWELL RX
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	217669	CONTRACT PHARMACAL
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	075718	DR REDDYS LABS LTD
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	218181	GRAVITI PHARMS
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	075511	IVAX SUB TEVA PHARMS
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	075302	MANKIND PHARMA
FAMOTIDINE	FAMOTIDINE	40MG	TABLET;ORAL	Prescription	No	AB	216441	ZYDUS PHARMS

Top