Details for New Drug Application (NDA): 208573
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NDA 208573 describes VENCLEXTA, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the VENCLEXTA profile page.
The generic ingredient in VENCLEXTA is venetoclax. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the venetoclax profile page.
The generic ingredient in VENCLEXTA is venetoclax. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the venetoclax profile page.
Summary for 208573
| Tradename: | VENCLEXTA |
| Applicant: | Abbvie |
| Ingredient: | venetoclax |
| Patents: | 10 |
Pharmacology for NDA: 208573
| Mechanism of Action | P-Glycoprotein Inhibitors |
| Physiological Effect | Increased Cellular Death |
Suppliers and Packaging for NDA: 208573
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VENCLEXTA | venetoclax | TABLET;ORAL | 208573 | NDA | AbbVie Inc. | 0074-0561 | 0074-0561-11 | 1 BLISTER PACK in 1 CARTON (0074-0561-11) / 2 TABLET, FILM COATED in 1 BLISTER PACK |
| VENCLEXTA | venetoclax | TABLET;ORAL | 208573 | NDA | AbbVie Inc. | 0074-0561 | 0074-0561-14 | 1 BLISTER PACK in 1 CARTON (0074-0561-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 11, 2016 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | May 15, 2026 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) | ||||||||
| Patent: | 10,730,873 | Patent Expiration: | Nov 21, 2031 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | 10,993,942 | Patent Expiration: | Sep 6, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK | ||||||||
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