Details for New Drug Application (NDA): 021986
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NDA 021986 describes SPRYCEL, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the SPRYCEL profile page.
The generic ingredient in SPRYCEL is dasatinib. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dasatinib profile page.
The generic ingredient in SPRYCEL is dasatinib. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dasatinib profile page.
Summary for 021986
| Tradename: | SPRYCEL |
| Applicant: | Bristol Myers Squibb |
| Ingredient: | dasatinib |
| Patents: | 2 |
Pharmacology for NDA: 021986
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for 021986
Suppliers and Packaging for NDA: 021986
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SPRYCEL | dasatinib | TABLET;ORAL | 021986 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0524 | 0003-0524-11 | 1 BOTTLE in 1 CARTON (0003-0524-11) / 60 TABLET in 1 BOTTLE |
| SPRYCEL | dasatinib | TABLET;ORAL | 021986 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0527 | 0003-0527-11 | 1 BOTTLE in 1 CARTON (0003-0527-11) / 60 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jun 28, 2006 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Dec 21, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 21, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | May 9, 2025 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Expired US Patents for NDA 021986
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-003 | Jun 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-006 | Oct 28, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-004 | May 30, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-001 | Jun 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-002 | Jun 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-005 | Oct 28, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-002 | Jun 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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