Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 007335
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRONESTYL PROCAINAMIDE HYDROCHLORIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
PRONESTYL PROCAINAMIDE HYDROCHLORIDE 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
PRONESTYL PROCAINAMIDE HYDROCHLORIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
PRONESTYL PROCAINAMIDE HYDROCHLORIDE 375MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
PRONESTYL PROCAINAMIDE HYDROCHLORIDE 500MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
06/02/1950 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

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-61 Labeling

Label is not available on this site.

09/12/1995 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

06/08/1992 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

10/03/1991 SUPPL-58 Efficacy-New Indication

Label is not available on this site.

12/22/1989 SUPPL-57 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/30/1989 SUPPL-56 Labeling

Label is not available on this site.

10/09/1987 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1987 SUPPL-54 Labeling

Label is not available on this site.

03/30/1989 SUPPL-53 Labeling

Label is not available on this site.

05/20/1986 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1984 SUPPL-51 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/12/1983 SUPPL-50 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/29/1985 SUPPL-49 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/04/1983 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

12/15/1982 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1982 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

05/09/1985 SUPPL-45 Labeling

Label is not available on this site.

01/27/1981 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/09/1985 SUPPL-43 Labeling

Label is not available on this site.

04/28/1980 SUPPL-42 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/06/1979 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1979 SUPPL-40 Labeling

Label is not available on this site.

06/30/1978 SUPPL-39 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/07/1978 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1978 SUPPL-37 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/21/1977 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1977 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1977 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1977 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/10/1978 SUPPL-30 Labeling

Label is not available on this site.

09/08/1976 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/08/1976 SUPPL-23 Unspecified

Label is not available on this site.

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