Details for New Drug Application (NDA): 211031
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NDA 211031 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 211031
| Tradename: | EXEMESTANE |
| Applicant: | Breckenridge |
| Ingredient: | exemestane |
| Patents: | 0 |
Pharmacology for NDA: 211031
| Mechanism of Action | Aromatase Inhibitors |
Suppliers and Packaging for NDA: 211031
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EXEMESTANE | exemestane | TABLET;ORAL | 211031 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-005 | 51991-005-90 | 90 TABLET, FILM COATED in 1 BOTTLE (51991-005-90) |
| EXEMESTANE | exemestane | TABLET;ORAL | 211031 | ANDA | Bryant Ranch Prepack | 63629-2056 | 63629-2056-1 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-2056-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Feb 21, 2019 | TE: | AB | RLD: | No | ||||
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