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Details for New Drug Application (NDA): 071826

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NDA 071826 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: 071826

Par Pharm
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 071826

Physiological EffectArteriolar Vasodilation

Suppliers and Packaging for NDA: 071826

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 071826 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7593 0615-7593-39 30 TABLET in 1 BLISTER PACK (0615-7593-39)
TABLET;ORAL 071826 ANDA REMEDYREPACK INC. 49349-654 49349-654-02 30 TABLET in 1 BLISTER PACK (49349-654-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Nov 14, 1988TE:ABRLD:No

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