Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076239
Company: EI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEROXIDIL 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
08/24/2004 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
07/21/2016 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/21/2016 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

THEROXIDIL

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

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