Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 089074
Company: PERRIGO CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STIE-CORT HYDROCORTISONE 2.5% LOTION;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
11/26/1985 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
11/28/2007 SUPPL-15 Labeling

Label is not available on this site.

08/16/2001 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/03/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/14/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/14/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/17/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/17/1996 SUPPL-9 Labeling

Label is not available on this site.

09/14/1995 SUPPL-8 Labeling

Label is not available on this site.

09/14/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/11/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/14/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/14/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

STIE-CORT

LOTION;TOPICAL; 2.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCORTISONE HYDROCORTISONE 2.5% LOTION;TOPICAL Prescription No AT 040351 FOUGERA PHARMS
HYDROCORTISONE HYDROCORTISONE 2.5% LOTION;TOPICAL Prescription No AT 040417 LANNETT CO INC
HYDROCORTISONE HYDROCORTISONE 2.5% LOTION;TOPICAL Prescription No AT 040247 TARO
HYDROCORTISONE HYDROCORTISONE 2.5% LOTION;TOPICAL Prescription No AT 203804 TELIGENT PHARMA INC
STIE-CORT HYDROCORTISONE 2.5% LOTION;TOPICAL Prescription No AT 089074 PERRIGO CO

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