Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018932
Company: TEVA WOMENS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REVIA NALTREXONE HYDROCHLORIDE 50MG TABLET;ORAL Discontinued None No No
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.

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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