Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075512
Company: P AND L
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FAMOTIDINE FAMOTIDINE 10MG TABLET;ORAL Over-the-counter None 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
07/26/2001 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/18/2008 SUPPL-9 Labeling

Label is not available on this site.

03/26/2008 SUPPL-8 Labeling

Label is not available on this site.

05/08/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

01/17/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

FAMOTIDINE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
FAMOTIDINE FAMOTIDINE 10MG TABLET;ORAL Over-the-counter No 206531 AUROBINDO PHARMA LTD
FAMOTIDINE FAMOTIDINE 10MG TABLET;ORAL Over-the-counter No 075758 DR REDDYS LABS LTD
FAMOTIDINE FAMOTIDINE 10MG TABLET;ORAL Over-the-counter No 075674 MYLAN
FAMOTIDINE FAMOTIDINE 10MG TABLET;ORAL Over-the-counter No 075512 P AND L
FAMOTIDINE FAMOTIDINE 10MG TABLET;ORAL Over-the-counter No 075400 PERRIGO
FAMOTIDINE FAMOTIDINE 10MG TABLET;ORAL Over-the-counter No 090283 SUN PHARM INDS LTD
FAMOTIDINE FAMOTIDINE 10MG TABLET;ORAL Over-the-counter No 075312 TEVA
FAMOTIDINE FAMOTIDINE 10MG TABLET;ORAL Over-the-counter No 077146 WOCKHARDT
PEPCID AC FAMOTIDINE 10MG TABLET;ORAL Over-the-counter Yes 020325 J AND J CONSUMER INC
PEPCID AC FAMOTIDINE 10MG TABLET;ORAL Over-the-counter No 020902 J AND J CONSUMER INC

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