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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018851
Company: HERITAGE

Medication Guide

Products on NDA 018851

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE;ORAL	Discontinued	None	No	No
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018851

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/18/1984	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
10/04/1989	SUPPL-31	Labeling		Label is not available on this site.
03/16/1989	SUPPL-30	Labeling		Label is not available on this site.
11/21/2024	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018851s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018851Orig1s029ltr.pdf
04/28/2021	SUPPL-28	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018851s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018851Orig1s028ltr.pdf
05/09/2016	SUPPL-25	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018851s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018851Orig1s025ltr.pdf
08/07/1992	SUPPL-23	Labeling		Label is not available on this site.
10/04/1989	SUPPL-22	Labeling		Label is not available on this site.
03/16/1989	SUPPL-21	Labeling		Label is not available on this site.
05/25/1990	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
02/13/1989	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
02/23/1988	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
02/13/1989	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/19/1986	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/14/1987	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/24/1985	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/24/1985	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/24/1985	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018851

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018851s029lbl.pdf
04/28/2021	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018851s028lbl.pdf
04/28/2021	SUPPL-28	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018851s028lbl.pdf
05/09/2016	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018851s025lbl.pdf
05/09/2016	SUPPL-25	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018851s025lbl.pdf

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