Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074727
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACYCLOVIR ACYCLOVIR 200MG CAPSULE;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
04/22/1997 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074727_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/07/2009 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/21/2004 SUPPL-8 Labeling

Label is not available on this site.

07/31/2002 SUPPL-6 Labeling

Label is not available on this site.

03/13/2002 SUPPL-5 Labeling

Label is not available on this site.

11/30/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/05/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/31/1998 SUPPL-2 Labeling

Label is not available on this site.

06/08/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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