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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074464
Company: SANDOZ

Products on ANDA 074464

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 074464

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/1998	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74464ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74464.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
02/02/2020	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
02/02/2020	SUPPL-19	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
03/13/2006	SUPPL-5	Labeling		Label is not available on this site.
03/13/2006	SUPPL-4	Labeling		Label is not available on this site.
02/02/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
02/12/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074464

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	074464	SANDOZ
INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	202711	ZYDUS PHARMS

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