Details for New Drug Application (NDA): 209543
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NDA 209543 describes BOSUTINIB MONOHYDRATE, which is a drug marketed by Alembic and is included in one NDA. It is available from two suppliers. Additional details are available on the BOSUTINIB MONOHYDRATE profile page.
The generic ingredient in BOSUTINIB MONOHYDRATE is bosutinib monohydrate. There are five drug master file entries for this compound. Four 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 are five drug master file entries for this compound. Four 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 | ||||
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 | ||||
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