Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 073085
Company: ACP NIMBLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription AB1 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
02/14/1992 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
07/05/2001 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/29/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/07/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/07/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/07/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/28/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/22/1993 SUPPL-1 Labeling

Label is not available on this site.

FLUOCINONIDE

CREAM;TOPICAL; 0.05%
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 073085 ACP NIMBLE
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 073030 FOUGERA PHARMS INC
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription Yes AB1 019117 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 071500 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 211410 TELIGENT PHARMA INC
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 072488 TEVA

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