Details for New Drug Application (NDA): 021812
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The generic ingredient in WOMEN'S ROGAINE is minoxidil. There are eight drug master file entries for this compound. Eighty suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
Summary for 021812
| Tradename: | WOMEN'S ROGAINE |
| Applicant: | Kenvue Brands |
| Ingredient: | minoxidil |
| Patents: | 0 |
Pharmacology for NDA: 021812
| Physiological Effect | Arteriolar Vasodilation |
Medical Subject Heading (MeSH) Categories for 021812
Suppliers and Packaging for NDA: 021812
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEN'S ROGAINE | minoxidil | AEROSOL, FOAM;TOPICAL | 021812 | NDA | Kenvue Brands LLC | 69968-0030 | 69968-0030-1 | 1 CAN in 1 CARTON (69968-0030-1) / 60 g in 1 CAN |
| MEN'S ROGAINE | minoxidil | AEROSOL, FOAM;TOPICAL | 021812 | NDA | Kenvue Brands LLC | 69968-0030 | 69968-0030-2 | 2 CAN in 1 CARTON (69968-0030-2) / 60 g in 1 CAN |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 5% | ||||
| Approval Date: | Jan 20, 2006 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 5% | ||||
| Approval Date: | Feb 28, 2014 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021812
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Kenvue Brands | MEN'S ROGAINE | minoxidil | AEROSOL, FOAM;TOPICAL | 021812-001 | Jan 20, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Kenvue Brands | WOMEN'S ROGAINE | minoxidil | AEROSOL, FOAM;TOPICAL | 021812-002 | Feb 28, 2014 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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