Details for New Drug Application (NDA): 218616
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NDA 218616 describes MINOXIDIL (FOR WOMEN), which is a drug marketed by Aurobindo Pharma, P And L, Taro, Apotex Inc, Aurobindo Pharma Ltd, Hikma, L Perrigo Co, and Sight Pharms, and is included in nine NDAs. It is available from thirty-seven suppliers. Additional details are available on the MINOXIDIL (FOR WOMEN) profile page.
The generic ingredient in MINOXIDIL (FOR WOMEN) 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 MINOXIDIL (FOR WOMEN) 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 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 | Aurohealth LLC | 58602-607 | 58602-607-01 | 1 CAN in 1 CARTON (58602-607-01) / 60 g in 1 CAN |
| MINOXIDIL (FOR MEN) | minoxidil | AEROSOL, FOAM;TOPICAL | 218616 | ANDA | Aurohealth LLC | 58602-607 | 58602-607-02 | 2 CAN in 1 CARTON (58602-607-02) / 60 g in 1 CAN |
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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