Details for New Drug Application (NDA): 202107
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The generic ingredient in KORLYM 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 202107
Tradename: | KORLYM |
Applicant: | Corcept Therap |
Ingredient: | mifepristone |
Patents: | 18 |
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 Incorporated | 76346-073 | 76346-073-01 | 28 TABLET in 1 BOTTLE (76346-073-01) |
KORLYM | mifepristone | TABLET;ORAL | 202107 | NDA | Corcept Therapeutics Incorporated | 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: | ⤷ Sign Up | Patent Expiration: | Aug 12, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATING CUSHING'S SYNDROME | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 18, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATING CUSHING'S SYNDROME | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 20, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATING CUSHING'S SYNDROME |
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