Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089707
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERPHENAZINE PERPHENAZINE 2MG 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
09/10/1987 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
07/29/2002 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

09/20/2002 SUPPL-20 Labeling

Label is not available on this site.

09/20/2002 SUPPL-19 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/28/2000 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

11/23/1999 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/28/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/19/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/07/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/28/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/26/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/08/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/04/1990 SUPPL-6 Labeling

Label is not available on this site.

02/23/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/20/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/20/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/28/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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