Details for New Drug Application (NDA): 209543
NDA 209543 describes BOSUTINIB MONOHYDRATE, which is a drug marketed by Alembic and MSN and is included in two NDAs. It is available from three suppliers. Additional details are available on the BOSUTINIB MONOHYDRATE profile page.
The generic ingredient in BOSUTINIB MONOHYDRATE is bosutinib monohydrate. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the bosutinib monohydrate profile page.
The generic ingredient in BOSUTINIB MONOHYDRATE is bosutinib monohydrate. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the bosutinib monohydrate profile page.
Summary for 209543
| Tradename: | BOSUTINIB MONOHYDRATE |
| Applicant: | Alembic |
| Ingredient: | bosutinib monohydrate |
| Patents: | 0 |
Pharmacology for NDA: 209543
| Mechanism of Action | Bcr-Abl Tyrosine Kinase Inhibitors |
Suppliers and Packaging for NDA: 209543
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BOSUTINIB MONOHYDRATE | bosutinib monohydrate | TABLET;ORAL | 209543 | ANDA | Alembic Pharmaceuticals Limited | 46708-311 | 46708-311-35 | 120 TABLET, FILM COATED in 1 BOTTLE (46708-311-35) |
| BOSUTINIB MONOHYDRATE | bosutinib monohydrate | TABLET;ORAL | 209543 | ANDA | Alembic Pharmaceuticals Limited | 46708-312 | 46708-312-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-312-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | May 23, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 23, 2026 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | May 23, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 23, 2026 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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