Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070101
Company: TEVA

Products on ANDA 070101

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DISOPYRAMIDE PHOSPHATE	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070101

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	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2015	SUPPL-46	Labeling-Package Insert		Label is not available on this site.
02/08/2001	SUPPL-41	Labeling		Label is not available on this site.
11/01/2000	SUPPL-40	Labeling		Label is not available on this site.
07/07/2000	SUPPL-39	Manufacturing (CMC)-Facility		Label is not available on this site.
05/16/2000	SUPPL-38	Manufacturing (CMC)-Facility		Label is not available on this site.
07/14/2000	SUPPL-37	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
07/14/2000	SUPPL-36	Manufacturing (CMC)-Facility		Label is not available on this site.
07/14/2000	SUPPL-35	Manufacturing (CMC)-Control		Label is not available on this site.
04/30/1999	SUPPL-34	Labeling		Label is not available on this site.
12/10/1997	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
04/07/1997	SUPPL-32	Labeling		Label is not available on this site.
06/18/1997	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
03/08/1995	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
01/23/1995	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
07/12/1996	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
07/31/1996	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
08/11/1992	SUPPL-25	Labeling		Label is not available on this site.
06/11/1992	SUPPL-24	Labeling		Label is not available on this site.
12/19/1991	SUPPL-23	Labeling		Label is not available on this site.
05/30/1991	SUPPL-22	Labeling		Label is not available on this site.
10/03/1990	SUPPL-21	Labeling		Label is not available on this site.
07/06/1988	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
10/30/1987	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.
04/14/1986	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/14/1986	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/10/1986	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/15/1985	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/15/1985	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/15/1985	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/24/1985	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/20/1985	SUPPL-6	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 070101

DISOPYRAMIDE PHOSPHATE

CAPSULE;ORAL; EQ 100MG 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 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	070173	DR REDDYS LABS SA
DISOPYRAMIDE PHOSPHATE	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	070101	TEVA
NORPACE	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	017447	PFIZER