Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091276
Company: GLENMARK PHARMS LTD

Products on ANDA 091276

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE;ORAL	Prescription	AB	No	No
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091276

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2010	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-6	Labeling-Package Insert		Label is not available on this site.
02/02/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/02/2020	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/09/2016	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 091276

INDOMETHACIN

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE;ORAL	Prescription	No	AB	018829	CHARTWELL MOLECULES
INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE;ORAL	Prescription	No	AB	091276	GLENMARK PHARMS LTD
INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE;ORAL	Prescription	No	AB	091240	HETERO LABS LTD III
INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE;ORAL	Prescription	No	AB	070673	SANDOZ
INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE;ORAL	Prescription	No	AB	090403	ZYDUS LIFESCIENCES

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Prescription	No	AB	018829	CHARTWELL MOLECULES
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Prescription	No	AB	070651	CHARTWELL MOLECULES
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Prescription	No	AB	091276	GLENMARK PHARMS LTD
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Prescription	No	AB	091240	HETERO LABS LTD III
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Prescription	No	AB	070674	SANDOZ
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Prescription	No	AB	090403	ZYDUS LIFESCIENCES