Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079175
Company: AVANTHI INC

Products on ANDA 079175

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079175

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/06/2009	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-21	Labeling-Package Insert		Label is not available on this site.
05/12/2021	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 079175

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