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 twenty-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. Eighty-six suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
The generic ingredient in THEROXIDIL is minoxidil. There are eight drug master file entries for this compound. Eighty-six 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 |
Pharmacology for NDA: 076239
| Physiological Effect | Arteriolar 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 | Topiderm, Inc. | 51326-160 | 51326-160-16 | 60 mL in 1 BOTTLE (51326-160-16) |
| THEROXIDIL | minoxidil | SOLUTION;TOPICAL | 076239 | ANDA | Topiderm, Inc | 51326-165 | 51326-165-01 | 1 KIT in 1 CARTON (51326-165-01) * 200 mL in 1 BOTTLE * 200 mL in 1 BOTTLE * 60 mL in 1 BOTTLE (51326-160-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;TOPICAL | Strength | 5% | ||||
| Approval Date: | Aug 24, 2004 | TE: | RLD: | No | |||||
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