Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018655
Company: PFIZER

Products on NDA 018655

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORPACE CR	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
NORPACE CR	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018655

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/1982	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
05/17/2000	SUPPL-33	Labeling		Label is not available on this site.
11/10/1998	SUPPL-32	Labeling		Label is not available on this site.
07/17/1998	SUPPL-31	Manufacturing (CMC)-Control		Label is not available on this site.
02/03/1998	SUPPL-30	Labeling		Label is not available on this site.
01/13/1997	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
06/28/1996	SUPPL-28	Labeling		Label is not available on this site.
12/21/1993	SUPPL-27	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/03/1991	SUPPL-26	Efficacy-New Indication		Label is not available on this site.
01/16/1992	SUPPL-25	Labeling		Label is not available on this site.
11/16/1989	SUPPL-24	Labeling		Label is not available on this site.
10/20/1989	SUPPL-23	Labeling		Label is not available on this site.
02/04/1988	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
08/28/1987	SUPPL-21	Labeling		Label is not available on this site.
06/30/1987	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
02/12/1987	SUPPL-19	Labeling		Label is not available on this site.
04/21/1987	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
05/30/1986	SUPPL-16	Labeling		Label is not available on this site.
05/06/1986	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/26/1985	SUPPL-14	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
06/18/1985	SUPPL-13	Labeling		Label is not available on this site.
01/25/1985	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
06/19/1985	SUPPL-11	Labeling		Label is not available on this site.
02/29/1984	SUPPL-10	Labeling		Label is not available on this site.
10/19/1983	SUPPL-9	Labeling		Label is not available on this site.
06/19/1985	SUPPL-8	Efficacy		Label is not available on this site.
09/06/1983	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
03/10/1983	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/10/1983	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/19/1985	SUPPL-4	Labeling		Label is not available on this site.
09/22/1982	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
09/21/1982	SUPPL-1	Labeling		Label is not available on this site.