Details for New Drug Application (NDA): 091178
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NDA 091178 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 091178
| Tradename: | MIFEPRISTONE |
| Applicant: | Genbiopro |
| Ingredient: | mifepristone |
| Patents: | 0 |
Pharmacology for NDA: 091178
| Mechanism of Action | Progestational Hormone Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 091178
Suppliers and Packaging for NDA: 091178
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIFEPRISTONE | mifepristone | TABLET;ORAL | 091178 | ANDA | GenBioPro, Inc. | 43393-001 | 43393-001-06 | 6 CARTON in 1 PACKAGE (43393-001-06) / 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (43393-001-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Apr 11, 2019 | TE: | AB | RLD: | No | ||||
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