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	Discontinued	None	No	No

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
10/16/2023	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
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.