Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089438
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE 750MG 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
03/23/1987 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
03/13/2002 SUPPL-18 Labeling

Label is not available on this site.

01/04/2002 SUPPL-17 Labeling

Label is not available on this site.

12/09/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/2002 SUPPL-15 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/09/2002 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

04/02/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

06/17/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/23/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/11/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/23/1995 SUPPL-8 Labeling

Label is not available on this site.

06/25/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/30/1991 SUPPL-6 Labeling

Label is not available on this site.

11/13/1991 SUPPL-5 Labeling

Label is not available on this site.

12/30/1991 SUPPL-4 Labeling

Label is not available on this site.

02/22/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/22/1991 SUPPL-2 Labeling

Label is not available on this site.

04/06/1989 SUPPL-1 Labeling

Label is not available on this site.

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