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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090128
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FAMCICLOVIR FAMCICLOVIR 125MG TABLET;ORAL Discontinued None No No
FAMCICLOVIR FAMCICLOVIR 250MG TABLET;ORAL Discontinued None No No
FAMCICLOVIR FAMCICLOVIR 500MG 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
03/21/2011 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
07/25/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

07/25/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

03/25/2016 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/23/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

08/02/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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