Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 084394
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SELENIUM SULFIDE SELENIUM SULFIDE 2.5% LOTION/SHAMPOO;TOPICAL 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
05/14/1975 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
12/06/2001 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/2001 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

01/25/1991 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

01/25/1991 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

07/18/1990 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

02/08/1989 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

02/08/1989 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

12/19/1989 SUPPL-50 Labeling

Label is not available on this site.

12/14/1984 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

01/18/1983 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

01/18/1983 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

01/18/1983 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

02/17/1983 SUPPL-43 Manufacturing (CMC)

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