Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091344
Company: PERRIGO ISRAEL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOXIDIL MINOXIDIL 5% AEROSOL, FOAM;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
04/28/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091344s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/03/2017 SUPPL-16 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/13/2016 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

MINOXIDIL

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

AEROSOL, FOAM;TOPICAL; 5%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
MEN'S ROGAINE MINOXIDIL 5% AEROSOL, FOAM;TOPICAL Over-the-counter Yes 021812 JOHNSON AND JOHNSON
MINOXIDIL MINOXIDIL 5% AEROSOL, FOAM;TOPICAL Over-the-counter No 091344 PERRIGO ISRAEL
MINOXIDIL (FOR MEN) MINOXIDIL 5% AEROSOL, FOAM;TOPICAL Over-the-counter No 208092 WATSON LABS INC
MINOXIDIL (FOR WOMEN) MINOXIDIL 5% AEROSOL, FOAM;TOPICAL Over-the-counter No 208092 WATSON LABS INC
WOMEN'S ROGAINE MINOXIDIL 5% AEROSOL, FOAM;TOPICAL Over-the-counter Yes 021812 JOHNSON AND JOHNSON

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