Details for New Drug Application (NDA): 202602
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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 202602
Tradename: | EXEMESTANE |
Applicant: | Zydus Pharms |
Ingredient: | exemestane |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202602
Mechanism of Action | Aromatase Inhibitors |
Suppliers and Packaging for NDA: 202602
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EXEMESTANE | exemestane | TABLET;ORAL | 202602 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-383 | 68382-383-06 | 30 TABLET in 1 BOTTLE (68382-383-06) |
EXEMESTANE | exemestane | TABLET;ORAL | 202602 | ANDA | Zydus Lifesciences Limited | 70771-1374 | 70771-1374-3 | 30 TABLET in 1 BOTTLE (70771-1374-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Oct 3, 2018 | TE: | AB | RLD: | No |
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