Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090403
Company: ZYDUS LIFESCIENCES

Products on ANDA 090403

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090403

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/15/2010	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
11/21/2024	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/09/2024	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/18/2019	SUPPL-3	Labeling		Label is not available on this site.
05/09/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090403

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