Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075311
Company: TEVA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/16/2001 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-311_Famotidine_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75311ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075311_famotidine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/26/2003 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/16/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-311_Famotidine_Prntlbl.pdf

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 075611 APOTEX
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 075718 DR REDDYS LABS LTD
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 075511 IVAX SUB TEVA PHARMS
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 075704 MYLAN
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 077352 PERRIGO R AND D
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 075311 TEVA
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Prescription No AB 075786 WOCKHARDT LTD
PEPCID FAMOTIDINE 20MG TABLET;ORAL Prescription Yes AB 019462 VALEANT PHARMS NORTH

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 075611 APOTEX
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 075718 DR REDDYS LABS LTD
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 075511 IVAX SUB TEVA PHARMS
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 077352 PERRIGO R AND D
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 075311 TEVA
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Prescription No AB 075786 WOCKHARDT LTD
PEPCID FAMOTIDINE 40MG TABLET;ORAL Prescription Yes AB 019462 VALEANT PHARMS NORTH

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