Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201807
Company: HETERO LABS LTD III

Products on ANDA 201807

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201807

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2012	ORIG-1	Approval	Not Applicable			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-5	Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 201807

INDOMETHACIN

CAPSULE, EXTENDED RELEASE;ORAL; 75MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	091549	AMNEAL PHARMS
INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	079175	AVANTHI INC
INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	200529	CHARTWELL RX
INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	203501	GLENMARK PHARMS LTD
INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	201807	HETERO LABS LTD III
INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	204853	NOVAST LABS
INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	202711	ZYDUS PHARMS