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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020752
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEPCID RPD FAMOTIDINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
PEPCID RPD FAMOTIDINE 40MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/06/2002 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf
05/28/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20752lbl.pdf
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