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FDA Approval

DASATINIB

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Aurobindo Pharma Limited
DUNS: 650082092
Effective Date
August 3, 2024
Labeling Type
Human Prescription Drug Label
Dasatinib(80 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

EUGIA Pharma Specialities Limited

Aurobindo Pharma Limited

872201704

Products6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

DASATINIB

Product Details

NDC Product Code
59651-545
Application Number
ANDA216547
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 3, 2024
DasatinibActive
Code: RBZ1571X5HClass: ACTIBQuantity: 80 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

DASATINIB

Product Details

NDC Product Code
59651-546
Application Number
ANDA216547
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 3, 2024
DasatinibActive
Code: RBZ1571X5HClass: ACTIBQuantity: 100 mg in 1 1
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

DASATINIB

Product Details

NDC Product Code
59651-547
Application Number
ANDA216547
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 3, 2024
DasatinibActive
Code: RBZ1571X5HClass: ACTIBQuantity: 140 mg in 1 1
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT

DASATINIB

Product Details

NDC Product Code
59651-544
Application Number
ANDA216547
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 3, 2024
DasatinibActive
Code: RBZ1571X5HClass: ACTIBQuantity: 70 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

DASATINIB

Product Details

NDC Product Code
59651-542
Application Number
ANDA216547
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 3, 2024
DasatinibActive
Code: RBZ1571X5HClass: ACTIBQuantity: 20 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

DASATINIB

Product Details

NDC Product Code
59651-543
Application Number
ANDA216547
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 3, 2024
DasatinibActive
Code: RBZ1571X5HClass: ACTIBQuantity: 50 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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