Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 014349
Company: PERSONAL PRODS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DELFEN NONOXYNOL-9 12.5% AEROSOL;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
12/10/1963 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/27/1989 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/29/1988 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/31/1988 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1986 SUPPL-30 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/18/1984 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1980 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1980 SUPPL-25 Labeling

Label is not available on this site.

10/27/1980 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/06/1980 SUPPL-23 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/24/1980 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/31/1979 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/31/1979 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/31/1979 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/23/1978 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/17/1978 SUPPL-12 Manufacturing (CMC)-Control

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