Details for New Drug Application (NDA): 211436
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NDA 211436 describes MIFEPRISTONE, which is a drug marketed by Genbiopro and Teva Pharms Usa Inc and is included in two NDAs. It is available from two 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. Three 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. Three suppliers are listed for this compound. Additional details are available on the mifepristone profile page.
Summary for 211436
| Tradename: | MIFEPRISTONE |
| Applicant: | Teva Pharms Usa Inc |
| Ingredient: | mifepristone |
| Patents: | 0 |
Pharmacology for NDA: 211436
| Mechanism of Action | Progestational Hormone Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 211436
Suppliers and Packaging for NDA: 211436
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIFEPRISTONE | mifepristone | TABLET;ORAL | 211436 | ANDA | Actavis Pharma, Inc. | 0591-4390 | 0591-4390-96 | 28 TABLET, FILM COATED in 1 BOTTLE (0591-4390-96) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Aug 3, 2020 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jul 17, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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