Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072711
Company: EPIC PHARMA

Products on ANDA 072711

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SULINDAC	SULINDAC	200MG	TABLET;ORAL	Prescription	AB	No	No
SULINDAC	SULINDAC	150MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072711

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/25/1991	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
11/21/2024	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
10/08/2024	SUPPL-17	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/28/2021	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/09/2016	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/28/2015	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/15/2010	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/01/2009	SUPPL-5	Labeling		Label is not available on this site.
05/13/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/12/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/27/1992	SUPPL-2	Labeling		Label is not available on this site.
05/06/1991	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 072711

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

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SULINDAC	SULINDAC	150MG	TABLET;ORAL	Prescription	No	AB	072711	EPIC PHARMA
SULINDAC	SULINDAC	150MG	TABLET;ORAL	Prescription	No	AB	072050	SUN PHARM INDUSTRIES
SULINDAC	SULINDAC	150MG	TABLET;ORAL	Prescription	No	AB	071891	WATSON LABS