Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 007335
Company: APOTHECON

Products on NDA 007335

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PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No
PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No
PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No
PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	500MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 007335

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	Note
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.
02/15/1978	SUPPL-33	Labeling	Label is not available on this site.
09/14/1977	SUPPL-32	Manufacturing (CMC)-Packaging	Label is not available on this site.
03/13/2009	SUPPL-31	Efficacy	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.