Details for New Drug Application (NDA): 078176
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NDA 078176 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. Seventy-seven 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. Seventy-seven suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
Summary for 078176
| Tradename: | THEROXIDIL |
| Applicant: | Pure Source |
| Ingredient: | minoxidil |
| Patents: | 0 |
Pharmacology for NDA: 078176
| Physiological Effect | Arteriolar Vasodilation |
Medical Subject Heading (MeSH) Categories for 078176
Suppliers and Packaging for NDA: 078176
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THEROXIDIL | minoxidil | SOLUTION;TOPICAL | 078176 | ANDA | Topiderm, Inc. | 51326-161 | 51326-161-01 | 60 mL in 1 BOTTLE (51326-161-01) |
| THEROXIDIL | minoxidil | SOLUTION;TOPICAL | 078176 | ANDA | Scientific Hair Research, LLC | 69113-432 | 69113-432-00 | 1 BOTTLE in 1 BOX (69113-432-00) / 60 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;TOPICAL | Strength | 2% | ||||
| Approval Date: | Nov 9, 2007 | TE: | RLD: | No | |||||
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