Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075529
Company: PERRIGO PHARMA INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRETINOIN TRETINOIN 0.025% GEL;TOPICAL Prescription AB 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
02/22/2000 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75529ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75529_Tretinoin.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/20/2007 SUPPL-10 Labeling

Label is not available on this site.

02/21/2007 SUPPL-8 Labeling

Label is not available on this site.

07/11/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

TRETINOIN

GEL;TOPICAL; 0.025%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RETIN-A TRETINOIN 0.025% GEL;TOPICAL Prescription Yes AB 017579 VALEANT INTL
TRETINOIN TRETINOIN 0.025% GEL;TOPICAL Prescription No AB 075529 PERRIGO PHARMA INTL

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