Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088974
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;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
07/22/1985 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
12/09/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/2002 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

12/09/2002 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

01/06/2003 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2002 SUPPL-19 Labeling

Label is not available on this site.

01/04/2002 SUPPL-18 Labeling

Label is not available on this site.

03/22/2002 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/02/2001 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

06/17/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/23/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/11/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/23/1995 SUPPL-11 Labeling

Label is not available on this site.

08/02/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/13/1991 SUPPL-9 Labeling

Label is not available on this site.

08/09/1991 SUPPL-8 Labeling

Label is not available on this site.

04/06/1989 SUPPL-7 Labeling

Label is not available on this site.

07/25/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/25/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/18/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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