Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 089440
Company: GENUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1% HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 1%;1% AEROSOL, METERED;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
05/17/1988 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
08/11/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/17/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/23/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/10/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/07/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/07/1998 SUPPL-2 Labeling

Label is not available on this site.

05/31/1996 SUPPL-1 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