Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017371
Company: APOTHECON

Products on NDA 017371

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017371

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.