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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018932
Company: TEVA WOMENS

Products on NDA 018932

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REVIA	NALTREXONE HYDROCHLORIDE	50MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018932

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/1984	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/03/2013	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018932s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018932Orig1s017ltr.pdf
05/15/2001	SUPPL-15	Labeling		Label is not available on this site.
03/05/1999	SUPPL-14	Labeling		Label is not available on this site.
03/05/1999	SUPPL-13	Labeling		Label is not available on this site.
06/23/1995	SUPPL-12	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/30/1994	SUPPL-11	Labeling		Label is not available on this site.
12/30/1994	SUPPL-10	Efficacy-New Indication		Label is not available on this site.
02/02/1989	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
04/28/1987	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
01/28/1986	SUPPL-3	Labeling		Label is not available on this site.
02/08/1985	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
11/30/1984	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 018932

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/03/2013	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018932s017lbl.pdf

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