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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074977
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
04/13/1998 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74977.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/12/2000 SUPPL-3 Labeling

Label is not available on this site.

12/20/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/14/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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