Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087146
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETASOL ACETIC ACID, GLACIAL 2% SOLUTION/DROPS;OTIC 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
08/12/1981 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
12/29/2000 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/07/1998 SUPPL-15 Labeling

Label is not available on this site.

11/17/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/14/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/22/1989 SUPPL-8 Labeling

Label is not available on this site.

09/15/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/17/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/17/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/17/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/13/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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