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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202711
Company: ZYDUS PHARMS

Products on ANDA 202711

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 202711

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/2017	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202711Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202711

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

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