Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070351
Company: SUN PHARM INDUSTRIES

Products on ANDA 070351

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DISOPYRAMIDE PHOSPHATE	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070351

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/1985	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
12/01/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
10/15/1992	SUPPL-21	Labeling		Label is not available on this site.
04/03/1992	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
11/21/1991	SUPPL-17	Labeling		Label is not available on this site.
09/30/1991	SUPPL-16	Labeling		Label is not available on this site.
08/22/1990	SUPPL-15	Labeling		Label is not available on this site.
10/09/1987	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/30/1987	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/08/1986	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/08/1986	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/22/1986	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/08/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/08/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.