Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087796
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 1% OINTMENT;TOPICAL Prescription AT 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
10/13/1982 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
04/26/2001 SUPPL-15 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/29/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/28/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/07/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/24/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/09/1994 SUPPL-9 Labeling

Label is not available on this site.

03/04/1992 SUPPL-8 Labeling

Label is not available on this site.

07/26/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/17/1993 SUPPL-6 Labeling

Label is not available on this site.

06/12/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/12/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/11/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

HYDROCORTISONE

OINTMENT;TOPICAL; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCORTISONE HYDROCORTISONE 1% OINTMENT;TOPICAL Prescription No AT 087796 ACTAVIS MID ATLANTIC
HYDROCORTISONE HYDROCORTISONE 1% OINTMENT;TOPICAL Prescription No AT 080692 FOUGERA PHARMS
HYDROCORTISONE HYDROCORTISONE 1% OINTMENT;TOPICAL Prescription No AT 086257 TARO
HYDROCORTISONE IN ABSORBASE HYDROCORTISONE 1% OINTMENT;TOPICAL Prescription No AT 088138 CMP PHARMA INC

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