Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075704
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FAMOTIDINE FAMOTIDINE 20MG TABLET;ORAL Discontinued None No No
FAMOTIDINE FAMOTIDINE 40MG TABLET;ORAL Discontinued 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
04/16/2001 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75704ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75704TA.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/13/2020 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

05/13/2020 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

05/16/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

06/27/2013 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

05/14/2003 SUPPL-3 Labeling

Label is not available on this site.

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