Details for New Drug Application (NDA): 216616
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NDA 216616 describes MIFEPRISTONE, which is a drug marketed by Evita Solutions, Genbiopro, and Teva Pharms Usa Inc, and is included in three NDAs. It is available from three suppliers. Additional details are available on the MIFEPRISTONE profile page.
The generic ingredient in MIFEPRISTONE is mifepristone. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the mifepristone profile page.
The generic ingredient in MIFEPRISTONE is mifepristone. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the mifepristone profile page.
Summary for 216616
| Tradename: | MIFEPRISTONE |
| Applicant: | Evita Solutions |
| Ingredient: | mifepristone |
| Patents: | 0 |
Pharmacology for NDA: 216616
| Mechanism of Action | Progestational Hormone Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 216616
Suppliers and Packaging for NDA: 216616
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIFEPRISTONE | mifepristone | TABLET;ORAL | 216616 | ANDA | Evita Solutions LLC | 84670-014 | 84670-014-01 | 1 TABLET in 1 BLISTER PACK (84670-014-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Sep 30, 2025 | TE: | AB | RLD: | No | ||||
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