Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 006110
Company: ORTHO MCNEIL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIENESTROL DIENESTROL 0.01% CREAM;VAGINAL 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
01/09/1947 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
12/07/1987 SUPPL-28 Labeling

Label is not available on this site.

04/01/1988 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/26/1986 SUPPL-26 Labeling

Label is not available on this site.

01/24/1985 SUPPL-24 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/01/1984 SUPPL-23 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/09/1983 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1984 SUPPL-21 Labeling

Label is not available on this site.

07/08/1982 SUPPL-20 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/29/1980 SUPPL-19 Efficacy

Label is not available on this site.

04/25/1980 SUPPL-17 Efficacy

Label is not available on this site.

04/25/1980 SUPPL-16 Efficacy

Label is not available on this site.

06/21/1979 SUPPL-15 Efficacy

Label is not available on this site.

04/25/1980 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1978 SUPPL-12 Labeling

Label is not available on this site.

04/17/1978 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1977 SUPPL-8 Labeling

Label is not available on this site.

09/27/1976 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/10/1976 SUPPL-5 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English