Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076668
Company: PERRIGO NEW YORK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.005% 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
05/14/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76668ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/16/2017 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

FLUTICASONE PROPIONATE

OINTMENT;TOPICAL; 0.005%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.005% OINTMENT;TOPICAL Prescription No AB 077168 ACP NIMBLE
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.005% OINTMENT;TOPICAL Prescription No AB 076668 PERRIGO NEW YORK

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