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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016131
Company: SANOFI AVENTIS US

Products on NDA 016131

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOMID	CLOMIPHENE CITRATE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016131

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/01/1967	ORIG-1	Approval	Type 1 - New Molecular Entity	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
12/18/2017	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016131s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016131Orig1s028ltr.pdf
10/22/2012	SUPPL-26	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016131s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016131s026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/016131Orig1s026.pdf
12/10/2002	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
10/25/1995	SUPPL-24	Labeling		Label is not available on this site.
09/30/1994	SUPPL-23	Labeling		Label is not available on this site.
02/22/1994	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
08/14/1991	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
04/27/1988	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/21/1993	SUPPL-17	Labeling		Label is not available on this site.
11/18/1981	SUPPL-15	Labeling		Label is not available on this site.
06/23/1980	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
06/23/1980	SUPPL-10	Labeling		Label is not available on this site.

Labels for NDA 016131

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2017	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016131s028lbl.pdf
10/22/2012	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016131s026lbl.pdf

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