Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084604
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE 250MG 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
12/02/1976 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-76 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-75 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-74 Manufacturing (CMC)-Facility

Label is not available on this site.

03/09/2000 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

03/09/2000 SUPPL-72 Manufacturing (CMC)-Facility

Label is not available on this site.

03/09/2000 SUPPL-71 Manufacturing (CMC)-Facility

Label is not available on this site.

11/23/1999 SUPPL-70 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1999 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

01/28/1999 SUPPL-68 Labeling

Label is not available on this site.

12/09/1998 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

05/30/1996 SUPPL-65 Labeling

Label is not available on this site.

03/20/1995 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

09/29/1992 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

01/31/1992 SUPPL-62 Labeling

Label is not available on this site.

06/17/1987 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

06/17/1987 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

12/15/1988 SUPPL-59 Labeling

Label is not available on this site.

04/02/1984 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

04/02/1984 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

03/01/1983 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

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