Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017371
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRONESTYL PROCAINAMIDE HYDROCHLORIDE 250MG TABLET;ORAL Discontinued None No No
PRONESTYL PROCAINAMIDE HYDROCHLORIDE 375MG TABLET;ORAL Discontinued None No No
PRONESTYL PROCAINAMIDE HYDROCHLORIDE 500MG 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
02/28/1974 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/06/1997 SUPPL-31 Labeling

Label is not available on this site.

09/06/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/17/1992 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/03/1991 SUPPL-28 Efficacy-New Indication

Label is not available on this site.

03/30/1989 SUPPL-27 Labeling

Label is not available on this site.

02/20/1987 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1986 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/1985 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/30/1985 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/31/1984 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/15/1983 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1983 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/13/1983 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/19/1981 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/08/1985 SUPPL-17 Labeling

Label is not available on this site.

08/27/1979 SUPPL-16 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/25/1979 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/28/1978 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/28/1978 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1978 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/27/1978 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1977 SUPPL-10 Labeling

Label is not available on this site.

03/13/2009 SUPPL-9 Efficacy

Label is not available on this site.

04/02/1976 SUPPL-8 Labeling

Label is not available on this site.

05/13/1975 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

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