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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 076239


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NDA 076239 describes THEROXIDIL, which is a drug marketed by Pure Source and is included in two NDAs. It is available from thirty-five suppliers. Additional details are available on the THEROXIDIL profile page.

The generic ingredient in THEROXIDIL is minoxidil. There are eight drug master file entries for this compound. Ninety-seven suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
Summary for 076239
Tradename:THEROXIDIL
Applicant:Pure Source
Ingredient:minoxidil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076239
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for 076239
Suppliers and Packaging for NDA: 076239
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEROXIDIL minoxidil SOLUTION;TOPICAL 076239 ANDA AVACOR PRODUCTS, LLC 49539-001 49539-001-01 3 BOTTLE in 1 CARTON (49539-001-01) / 60 mL in 1 BOTTLE
THEROXIDIL minoxidil SOLUTION;TOPICAL 076239 ANDA Topiderm, Inc. 51326-160 51326-160-16 60 mL in 1 BOTTLE (51326-160-16)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength5%
Approval Date:Aug 24, 2004TE:RLD:No

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