Details for New Drug Application (NDA): 217998
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NDA 217998 describes MINOXIDIL EXTRA STRENGTH (FOR MEN), which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Avacor Prods, P And L, Perrigo, Perrigo New York, and Taro, and is included in seven NDAs. It is available from twenty-three suppliers. Additional details are available on the MINOXIDIL EXTRA STRENGTH (FOR MEN) profile page.
The generic ingredient in MINOXIDIL EXTRA STRENGTH (FOR MEN) is minoxidil. There are eight drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
The generic ingredient in MINOXIDIL EXTRA STRENGTH (FOR MEN) is minoxidil. There are eight drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
Summary for 217998
| Tradename: | MINOXIDIL EXTRA STRENGTH (FOR MEN) |
| Applicant: | Taro |
| Ingredient: | minoxidil |
| Patents: | 0 |
Pharmacology for NDA: 217998
| Physiological Effect | Arteriolar Vasodilation |
Medical Subject Heading (MeSH) Categories for 217998
Suppliers and Packaging for NDA: 217998
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MINOXIDIL EXTRA STRENGTH (FOR MEN) | minoxidil | SOLUTION;TOPICAL | 217998 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-2151 | 51672-2151-4 | 1 BOTTLE in 1 CARTON (51672-2151-4) / 60 mL in 1 BOTTLE |
| MINOXIDIL EXTRA STRENGTH (FOR MEN) | minoxidil | SOLUTION;TOPICAL | 217998 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-2151 | 51672-2151-9 | 3 BOTTLE in 1 CARTON (51672-2151-9) / 60 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;TOPICAL | Strength | 5% | ||||
| Approval Date: | Jun 30, 2025 | TE: | RLD: | No | |||||
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