Details for New Drug Application (NDA): 019501
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NDA 019501 describes ROGAINE (FOR WOMEN), which is a drug marketed by Johnson And Johnson and is included in one NDA. It is available from one supplier. Additional details are available on the ROGAINE (FOR WOMEN) profile page.
The generic ingredient in ROGAINE (FOR WOMEN) is minoxidil. There are eight drug master file entries for this compound. One hundred and six suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
The generic ingredient in ROGAINE (FOR WOMEN) is minoxidil. There are eight drug master file entries for this compound. One hundred and six suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
Summary for 019501
| Tradename: | ROGAINE (FOR WOMEN) |
| Applicant: | Johnson And Johnson |
| Ingredient: | minoxidil |
| Patents: | 0 |
Pharmacology for NDA: 019501
| Physiological Effect | Arteriolar Vasodilation |
Medical Subject Heading (MeSH) Categories for 019501
Suppliers and Packaging for NDA: 019501
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROGAINE (FOR MEN) | minoxidil | SOLUTION;TOPICAL | 019501 | NDA | Kenvue Brands LLC | 69968-0090 | 69968-0090-1 | 1 BOTTLE, PLASTIC in 1 CARTON (69968-0090-1) / 60 mL in 1 BOTTLE, PLASTIC |
| ROGAINE (FOR MEN) | minoxidil | SOLUTION;TOPICAL | 019501 | NDA | Kenvue Brands LLC | 69968-0090 | 69968-0090-3 | 3 BOTTLE, PLASTIC in 1 CARTON (69968-0090-3) / 60 mL in 1 BOTTLE, PLASTIC |
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;TOPICAL | Strength | 2% | ||||
| Approval Date: | Feb 9, 1996 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;TOPICAL | Strength | 2% | ||||
| Approval Date: | Feb 9, 1996 | TE: | RLD: | Yes | |||||
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