Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078176
Company: EI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEROXIDIL MINOXIDIL 2% 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
11/09/2007 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-6 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; 2%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 074731 HI TECH PHARMA
MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 075357 L PERRIGO CO
MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 074588 P AND L
MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 074767 WOCKHARDT BIO AG
MINOXIDIL (FOR WOMEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 074731 HI TECH PHARMA
MINOXIDIL (FOR WOMEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 075357 L PERRIGO CO
ROGAINE (FOR MEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter Yes 019501 JOHNSON AND JOHNSON
ROGAINE (FOR WOMEN) MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter Yes 019501 JOHNSON AND JOHNSON
THEROXIDIL MINOXIDIL 2% SOLUTION;TOPICAL Over-the-counter No 078176 EI INC

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