Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073282
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLEMASTINE FUMARATE CLEMASTINE FUMARATE 1.34MG TABLET;ORAL Discontinued None No No
CLEMASTINE FUMARATE CLEMASTINE FUMARATE 1.34MG 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
01/31/1992 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
08/30/2001 SUPPL-35 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-34 Manufacturing (CMC)-Facility

Label is not available on this site.

08/02/2000 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/01/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/26/1996 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/13/1996 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/01/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/27/1996 SUPPL-23 Labeling

Label is not available on this site.

10/03/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/10/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/07/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/03/1992 SUPPL-2 Labeling

Label is not available on this site.

03/08/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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