Details for New Drug Application (NDA): 202107
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NDA 202107 describes KORLYM, which is a drug marketed by Corcept Therap and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the KORLYM profile page.
The generic ingredient in KORLYM is mifepristone. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mifepristone profile page.
The generic ingredient in KORLYM is mifepristone. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mifepristone profile page.
Summary for 202107
| Tradename: | KORLYM |
| Applicant: | Corcept Therap |
| Ingredient: | mifepristone |
| Patents: | 16 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202107
| Mechanism of Action | Progestational Hormone Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 202107
Suppliers and Packaging for NDA: 202107
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KORLYM | mifepristone | TABLET;ORAL | 202107 | NDA | Corcept Therapeutics | 76346-073 | 76346-073-01 | 28 TABLET in 1 BOTTLE (76346-073-01) |
| KORLYM | mifepristone | TABLET;ORAL | 202107 | NDA | Corcept Therapeutics | 76346-073 | 76346-073-02 | 280 TABLET in 1 BOTTLE (76346-073-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Feb 17, 2012 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 12, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATING CUSHING'S SYNDROME | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 18, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATING CUSHING'S SYNDROME | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 20, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATING CUSHING'S SYNDROME | ||||||||
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