Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075737
Company: PERRIGO NEW YORK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION;TOPICAL Over-the-counter None 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
03/15/2002 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75737.AP.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075737Orig1s000.pdf

MINOXIDIL EXTRA STRENGTH (FOR MEN)

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SOLUTION;TOPICAL; 5%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION;TOPICAL Over-the-counter No 075619 AVACOR PRODS
MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION;TOPICAL Over-the-counter No 075518 P AND L
MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION;TOPICAL Over-the-counter No 075598 PERRIGO
MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION;TOPICAL Over-the-counter No 075737 PERRIGO NEW YORK
MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION;TOPICAL Over-the-counter No 075438 WOCKHARDT BIO AG
ROGAINE EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION;TOPICAL Over-the-counter Yes 020834 JOHNSON AND JOHNSON
THEROXIDIL MINOXIDIL 5% SOLUTION;TOPICAL Over-the-counter No 076239 EI INC

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