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Details for New Drug Application (NDA): 071345

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NDA 071345 describes MINOXIDIL, which is a drug marketed by Mutual Pharm, Sun Pharm Inds, Par Pharm, Usl Pharma, Perrigo Israel, Watson Labs, Royce Labs, Copley Pharm, Apotex Inc, Hi Tech Pharma, Bausch And Lomb, Sight Pharms, Perrigo, Wockhardt, Actavis Mid Atlantic, Teva, Avacor Prods, and Perrigo New York, and is included in twenty-five NDAs. It is available from thirty-one 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. Fifty-five suppliers are listed for this compound. Additional details are available on the minoxidil profile page.

Summary for NDA: 071345

Tradename:
MINOXIDIL
Applicant:
Watson Labs
Ingredient:
minoxidil
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 071345

Physiological EffectArteriolar Vasodilation

Suppliers and Packaging for NDA: 071345

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOXIDIL
minoxidil
TABLET;ORAL 071345 ANDA Watson Laboratories, Inc. 0591-5643 0591-5643-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-5643-01)
MINOXIDIL
minoxidil
TABLET;ORAL 071345 ANDA Watson Laboratories, Inc. 0591-5643 0591-5643-05 500 TABLET in 1 BOTTLE, PLASTIC (0591-5643-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 3, 1987TE:ABRLD:Yes


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