Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073314
Company: COSETTE

Products on ANDA 073314

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073314

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/1992	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-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/11/2019	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
09/11/2019	SUPPL-22	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/29/2011	SUPPL-12	Labeling-Container/Carton Labels		Label is not available on this site.
03/13/2006	SUPPL-7	Labeling		Label is not available on this site.
01/28/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/04/1993	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 073314

INDOMETHACIN

SUPPOSITORY;RECTAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INDOMETHACIN	INDOMETHACIN	50MG	SUPPOSITORY;RECTAL	Prescription	No	AB	073314	COSETTE
INDOMETHACIN	INDOMETHACIN	50MG	SUPPOSITORY;RECTAL	Prescription	No	AB	216184	ZYDUS