Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071826
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOXIDIL MINOXIDIL 2.5MG TABLET;ORAL 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
11/14/1988 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
04/09/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

04/09/2015 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/21/2003 SUPPL-5 Labeling

Label is not available on this site.

11/26/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/26/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/02/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/08/1993 SUPPL-1 Labeling

Label is not available on this site.

MINOXIDIL

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINOXIDIL MINOXIDIL 2.5MG TABLET;ORAL Prescription No AB 071826 PAR PHARM
MINOXIDIL MINOXIDIL 2.5MG TABLET;ORAL Prescription No AB 072709 SUN PHARM INDUSTRIES
MINOXIDIL MINOXIDIL 2.5MG TABLET;ORAL Prescription No AB 071344 WATSON LABS

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