Details for New Drug Application (NDA): 091344
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NDA 091344 describes MINOXIDIL, which is a drug marketed by Perrigo Pharma Intl, Par Pharm, Royce Labs, Sun Pharm Industries, Usl Pharma, Watson Labs, P And L, Taro, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hikma, L Perrigo Co, Sight Pharms, Teva, Avacor Prods, Perrigo, and Perrigo New York, and is included in twenty-six NDAs. It is available from twenty-nine suppliers. Additional details are available on the MINOXIDIL profile page.
The generic ingredient in MINOXIDIL is minoxidil. There are eight drug master file entries for this compound. Ninety-four suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
The generic ingredient in MINOXIDIL is minoxidil. There are eight drug master file entries for this compound. Ninety-four suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
Summary for 091344
| Tradename: | MINOXIDIL |
| Applicant: | Perrigo Pharma Intl |
| Ingredient: | minoxidil |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091344
| Physiological Effect | Arteriolar Vasodilation |
Medical Subject Heading (MeSH) Categories for 091344
Suppliers and Packaging for NDA: 091344
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MINOXIDIL | minoxidil | AEROSOL, FOAM;TOPICAL | 091344 | ANDA | L. Perrigo Company | 0113-1129 | 0113-1129-06 | 6 CAN in 1 CARTON (0113-1129-06) / 60 g in 1 CAN |
| MINOXIDIL | minoxidil | AEROSOL, FOAM;TOPICAL | 091344 | ANDA | Walgreen Company | 0363-2294 | 0363-2294-01 | 1 CAN in 1 CARTON (0363-2294-01) / 60 g in 1 CAN |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 5% | ||||
| Approval Date: | Apr 28, 2011 | TE: | RLD: | No | |||||
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