Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075715
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FAMOTIDINE FAMOTIDINE 10MG TABLET, CHEWABLE;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
08/22/2003 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
10/12/2004 SUPPL-4 Labeling

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, CHEWABLE;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
FAMOTIDINE FAMOTIDINE 10MG TABLET, CHEWABLE;ORAL Over-the-counter No 075715 PERRIGO

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