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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071795
Company: WATSON LABS

Products on ANDA 071795

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SULINDAC	SULINDAC	200MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071795

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/03/1988	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
04/28/2021	SUPPL-44	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/17/2015	SUPPL-41	Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
10/08/2008	SUPPL-28	Labeling		Label is not available on this site.
02/05/2008	SUPPL-26	Labeling		Label is not available on this site.
06/05/2007	SUPPL-20	Labeling		Label is not available on this site.
02/17/2006	SUPPL-19	Labeling		Label is not available on this site.
04/25/2001	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
10/25/2001	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/2002	SUPPL-14	Labeling		Label is not available on this site.
01/28/2000	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/15/1998	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/15/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/22/1990	SUPPL-7	Labeling		Label is not available on this site.
10/15/1990	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/15/1990	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/29/1990	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/07/1989	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 071795

SULINDAC

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SULINDAC	SULINDAC	200MG	TABLET;ORAL	Prescription	No	AB	072711	EPIC PHARMA
SULINDAC	SULINDAC	200MG	TABLET;ORAL	Prescription	No	AB	072051	SUN PHARM INDUSTRIES
SULINDAC	SULINDAC	200MG	TABLET;ORAL	Prescription	No	AB	071795	WATSON LABS

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