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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 071839


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NDA 071839 describes MINOXIDIL, which is a drug marketed by Perrigo Pharma Intl, Par Pharm, Royce Labs, Sun Pharm Industries, Usl Pharma, Watson Labs, P And L, Taro, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hikma, L Perrigo Co, Sight Pharms, Teva, Avacor Prods, Perrigo, and Perrigo New York, and is included in twenty-six NDAs. It is available from twenty-nine suppliers. Additional details are available on the MINOXIDIL profile page.

The generic ingredient in MINOXIDIL is minoxidil. There are eight drug master file entries for this compound. Ninety-five suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
Summary for 071839
Tradename:MINOXIDIL
Applicant:Par Pharm
Ingredient:minoxidil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 071839
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for 071839
Suppliers and Packaging for NDA: 071839
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOXIDIL minoxidil TABLET;ORAL 071839 ANDA Par Pharmaceutical, Inc. 49884-257 49884-257-01 100 TABLET in 1 BOTTLE (49884-257-01)
MINOXIDIL minoxidil TABLET;ORAL 071839 ANDA Par Pharmaceutical, Inc. 49884-257 49884-257-05 500 TABLET in 1 BOTTLE (49884-257-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 14, 1988TE:ABRLD:No

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