Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075511
Company: IVAX SUB TEVA PHARMS
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 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75511ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2014 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

12/19/2012 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

07/06/2010 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

02/27/2008 SUPPL-8 Labeling

Label is not available on this site.

11/19/2003 SUPPL-5 Labeling

Label is not available on this site.

12/20/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

05/08/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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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