Details for New Drug Application (NDA): 218616
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The generic ingredient in MINOXIDIL (FOR WOMEN) is minoxidil. There are eight drug master file entries for this compound. Eighty-two suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
Summary for 218616
| Tradename: | MINOXIDIL (FOR WOMEN) |
| Applicant: | Aurobindo Pharma |
| Ingredient: | minoxidil |
| Patents: | 0 |
Pharmacology for NDA: 218616
| Physiological Effect | Arteriolar Vasodilation |
Medical Subject Heading (MeSH) Categories for 218616
Suppliers and Packaging for NDA: 218616
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MINOXIDIL (FOR MEN) | minoxidil | AEROSOL, FOAM;TOPICAL | 218616 | ANDA | INNOVUS PHARMACEUTICALS, INC. | 57483-165 | 57483-165-13 | 3 CAN in 1 CARTON (57483-165-13) / 60 g in 1 CAN (57483-165-01) |
| MINOXIDIL (FOR MEN) | minoxidil | AEROSOL, FOAM;TOPICAL | 218616 | ANDA | INNOVUS PHARMACEUTICALS, INC. | 57483-175 | 57483-175-12 | 2 CAN in 1 CARTON (57483-175-12) / 60 g in 1 CAN (57483-175-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 5% | ||||
| Approval Date: | Apr 22, 2024 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 5% | ||||
| Approval Date: | Apr 22, 2024 | TE: | RLD: | No | |||||
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