Details for New Drug Application (NDA): 020834
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NDA 020834 describes ROGAINE EXTRA STRENGTH (FOR MEN), which is a drug marketed by Kenvue Brands and is included in one NDA. It is available from one supplier. Additional details are available on the ROGAINE EXTRA STRENGTH (FOR MEN) profile page.
The generic ingredient in ROGAINE EXTRA STRENGTH (FOR MEN) 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 ROGAINE EXTRA STRENGTH (FOR MEN) 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 020834
| Tradename: | ROGAINE EXTRA STRENGTH (FOR MEN) |
| Applicant: | Kenvue Brands |
| Ingredient: | minoxidil |
| Patents: | 0 |
Pharmacology for NDA: 020834
| Physiological Effect | Arteriolar Vasodilation |
Medical Subject Heading (MeSH) Categories for 020834
Suppliers and Packaging for NDA: 020834
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROGAINE EXTRA STRENGTH (FOR MEN) | minoxidil | SOLUTION;TOPICAL | 020834 | NDA | Kenvue Brands LLC | 69968-0089 | 69968-0089-1 | 1 BOTTLE, PLASTIC in 1 CARTON (69968-0089-1) / 60 mL in 1 BOTTLE, PLASTIC |
| ROGAINE EXTRA STRENGTH (FOR MEN) | minoxidil | SOLUTION;TOPICAL | 020834 | NDA | Kenvue Brands LLC | 69968-0089 | 69968-0089-3 | 3 BOTTLE, PLASTIC in 1 CARTON (69968-0089-3) / 60 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;TOPICAL | Strength | 5% | ||||
| Approval Date: | Nov 14, 1997 | TE: | RLD: | Yes | |||||
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