Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074836
Company: IVAX SUB TEVA PHARMS
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
04/22/1997 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
08/17/2006 SUPPL-28 Labeling

Label is not available on this site.

03/14/2005 SUPPL-26 Labeling

Label is not available on this site.

07/29/2002 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

11/05/2002 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/12/2002 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2001 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

01/04/2001 SUPPL-14 Labeling

Label is not available on this site.

06/07/2000 SUPPL-13 Labeling

Label is not available on this site.

12/21/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/28/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

06/07/2000 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/08/1999 SUPPL-9 Labeling

Label is not available on this site.

06/15/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/15/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/15/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/15/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/09/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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