Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076884
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT;TOPICAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/18/2005 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
08/31/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

ALCLOMETASONE DIPROPIONATE

OINTMENT;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 076884 FOUGERA PHARMS
ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 079227 GLENMARK GENERICS
ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT;TOPICAL Prescription No AB 076730 TARO

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