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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018878
Company: RECORDATI RARE

Products on NDA 018878

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDOCIN	INDOMETHACIN SODIUM	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018878

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/1985	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2021	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018878s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018878Orig1s029ltr.pdf
01/19/2010	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018878s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018878s027ltr.pdf
01/12/2007	SUPPL-24	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018878s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018878s024ltr.pdf
02/01/2006	SUPPL-23	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018878s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018878s023ltr.pdf
11/08/2002	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
05/06/2003	SUPPL-19	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18878slr018,019ltr.pdf
05/06/2003	SUPPL-18	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18878slr018,019ltr.pdf
02/12/2001	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
11/16/2000	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
10/24/2000	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/1998	SUPPL-14	Labeling		Label is not available on this site.
10/14/1997	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
09/13/1994	SUPPL-11	Labeling		Label is not available on this site.
09/21/1994	SUPPL-10	Labeling		Label is not available on this site.
06/08/1988	SUPPL-5	Labeling		Label is not available on this site.
06/20/1985	SUPPL-2	Labeling		Label is not available on this site.
10/31/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018878

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2021	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018878s029lbl.pdf
01/19/2010	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018878s027lbl.pdf
01/12/2007	SUPPL-24	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018878s024lbl.pdf
02/01/2006	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018878s023lbl.pdf

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