Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084595
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE 375MG CAPSULE;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
06/14/1977 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-50 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-49 Manufacturing (CMC)-Facility

Label is not available on this site.

07/23/2001 SUPPL-48 Manufacturing (CMC)-Facility

Label is not available on this site.

07/23/2001 SUPPL-47 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-46 Manufacturing (CMC)-Facility

Label is not available on this site.

03/21/2000 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

11/23/1999 SUPPL-44 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1999 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

01/28/1999 SUPPL-42 Labeling

Label is not available on this site.

12/09/1998 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/08/1998 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

05/30/1996 SUPPL-38 Labeling

Label is not available on this site.

03/20/1995 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

09/29/1992 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

01/31/1992 SUPPL-35 Labeling

Label is not available on this site.

12/15/1988 SUPPL-34 Labeling

Label is not available on this site.

06/15/1987 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/15/1987 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/02/1984 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/02/1984 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/31/1982 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

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