Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 070102
Company: TEVA

Products on ANDA 070102

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DISOPYRAMIDE PHOSPHATE	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070102

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/1985	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Note
04/29/2015	SUPPL-51	Labeling-Container/Carton Labels, Labeling-Package Insert	Label is not available on this site.
02/08/2007	SUPPL-49	Manufacturing (CMC)-Control	Label is not available on this site.
02/08/2001	SUPPL-46	Labeling	Label is not available on this site.
11/01/2000	SUPPL-45	Labeling	Label is not available on this site.
07/07/2000	SUPPL-44	Manufacturing (CMC)-Facility	Label is not available on this site.
05/16/2000	SUPPL-43	Manufacturing (CMC)-Facility	Label is not available on this site.
10/31/2000	SUPPL-42	Manufacturing (CMC)-Manufacturing Process	Label is not available on this site.
10/31/2000	SUPPL-41	Manufacturing (CMC)-Facility	Label is not available on this site.
10/31/2000	SUPPL-40	Manufacturing (CMC)-Control	Label is not available on this site.
04/30/1999	SUPPL-39	Labeling	Label is not available on this site.
12/10/1997	SUPPL-38	Manufacturing (CMC)	Label is not available on this site.
04/07/1997	SUPPL-37	Labeling	Label is not available on this site.
06/18/1997	SUPPL-36	Manufacturing (CMC)	Label is not available on this site.
03/08/1995	SUPPL-34	Manufacturing (CMC)	Label is not available on this site.
01/23/1995	SUPPL-33	Manufacturing (CMC)	Label is not available on this site.
07/12/1996	SUPPL-32	Manufacturing (CMC)	Label is not available on this site.
07/31/1996	SUPPL-31	Manufacturing (CMC)	Label is not available on this site.
08/11/1992	SUPPL-30	Labeling	Label is not available on this site.
06/11/1992	SUPPL-29	Labeling	Label is not available on this site.
12/19/1991	SUPPL-28	Labeling	Label is not available on this site.
05/30/1991	SUPPL-27	Labeling	Label is not available on this site.
10/03/1990	SUPPL-26	Labeling	Label is not available on this site.
07/06/1988	SUPPL-25	Manufacturing (CMC)	Label is not available on this site.
10/30/1987	SUPPL-23	Manufacturing (CMC)	Label is not available on this site.
10/10/1986	SUPPL-22	Manufacturing (CMC)	Label is not available on this site.
04/14/1986	SUPPL-19	Manufacturing (CMC)	Label is not available on this site.
04/14/1986	SUPPL-18	Manufacturing (CMC)	Label is not available on this site.
10/10/1986	SUPPL-17	Manufacturing (CMC)	Label is not available on this site.
08/15/1985	SUPPL-14	Manufacturing (CMC)	Label is not available on this site.
08/15/1985	SUPPL-12	Manufacturing (CMC)	Label is not available on this site.
05/20/1985	SUPPL-8	Manufacturing (CMC)	Label is not available on this site.
05/20/1985	SUPPL-7	Manufacturing (CMC)	Label is not available on this site.
05/20/1985	SUPPL-5	Manufacturing (CMC)	Label is not available on this site.
05/20/1985	SUPPL-4	Manufacturing (CMC)	Label is not available on this site.
05/20/1985	SUPPL-3	Manufacturing (CMC)	Label is not available on this site.
05/20/1985	SUPPL-2	Manufacturing (CMC)	Label is not available on this site.

Therapeutic Equivalents for ANDA 070102

DISOPYRAMIDE PHOSPHATE

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DISOPYRAMIDE PHOSPHATE	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	070173	DR REDDYS LABS SA
DISOPYRAMIDE PHOSPHATE	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	070102	TEVA
NORPACE	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	017447	PFIZER