Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074870
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACYCLOVIR ACYCLOVIR 400MG TABLET;ORAL Discontinued None No No
ACYCLOVIR ACYCLOVIR 800MG 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
06/05/1997 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074870_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/28/2004 SUPPL-9 Labeling

Label is not available on this site.

04/23/2002 SUPPL-5 Labeling

Label is not available on this site.

11/02/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/2000 SUPPL-3 Labeling

Label is not available on this site.

08/10/1998 SUPPL-2 Labeling

Label is not available on this site.

03/26/1998 SUPPL-1 Labeling

Label is not available on this site.

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