Details for New Drug Application (NDA): 077431
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NDA 077431 describes EXEMESTANE, which is a drug marketed by Alvogen, Amneal Pharms, Breckenridge, Cipla, Dr Reddys Labs Sa, Eugia Pharma, Hikma, Qilu, Rising, Upsher Smith Labs, and Zydus Pharms, and is included in eleven NDAs. It is available from eleven suppliers. Additional details are available on the EXEMESTANE profile page.
The generic ingredient in EXEMESTANE is exemestane. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the exemestane profile page.
The generic ingredient in EXEMESTANE is exemestane. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the exemestane profile page.
Summary for 077431
| Tradename: | EXEMESTANE |
| Applicant: | Hikma |
| Ingredient: | exemestane |
| Patents: | 0 |
Pharmacology for NDA: 077431
| Mechanism of Action | Aromatase Inhibitors |
Suppliers and Packaging for NDA: 077431
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EXEMESTANE | exemestane | TABLET;ORAL | 077431 | ANDA | Hikma Pharmaceuticals USA Inc | 0054-0080 | 0054-0080-13 | 30 TABLET, FILM COATED in 1 BOTTLE (0054-0080-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Apr 1, 2011 | TE: | AB | RLD: | No | ||||
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