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Medicine

Dasatinib 50 mg tablet

Dasatinib · Oral
Available on requestPrescription onlyUS FDAGeneric name

Dasatinib 50 mg tablet is a generic prescription medicine for oral use, made by 14 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C…

Key facts

Active ingredient (INN)
Dasatinib
Brand
Sold under the generic name
Strength
50 mg
Dosage form
Tablet
Route
Oral
Packs
60 tablets, 1 blister pack, 1 bottle and 14 more
Manufacturers
Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaZydus LifesciencesIndiaBioconIndiaDr. Reddy's LaboratoriesIndiaLupinIndiaNovadoz PharmaceuticalsIndiaApotexAvKAREBluePoint Laboratories
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
L01EA02 Dasatinib
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
3 September 2024
Identifiers
RxCUI 643105, 643107, 643109 +3DailyMed set ID 2ed87763-f018-abdb-c0ab-daa5e441b397, 43e078b9-4e0b-edeb-e063-6294a90a7586, 4582bf1e-d0c4-88ec-f76c-4670bd7b14ad +13NDC 60505-3629, 73190-047, 82009-193 +13Application ANDA202103, ANDA211094, ANDA217217 +7

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
60 tablet, film coated in 1 bottle46708-685-60Alembic PharmaceuticalsIndia11 November 2025
60 tablet, film coated in 1 bottle62332-685-60Alembic PharmaceuticalsIndia11 November 2025
60 tablet in 1 bottle70710-1742-6Zydus LifesciencesIndia3 March 2025
60 tablet in 1 bottle70771-1902-6Zydus LifesciencesIndia3 March 2025
1 blister pack in 1 carton / 15 tablet in 1 blister pack59651-543-15Aurobindo PharmaIndia22 April 2025
60 tablet in 1 bottle59651-543-60Aurobindo PharmaIndia22 April 2025
60 tablet, film coated in 1 bottle70377-084-11BioconIndia3 March 2025
60 tablet, film coated in 1 bottle43598-600-60Dr. Reddy's LaboratoriesIndia3 March 2025
1 bottle in 1 carton / 60 tablet in 1 bottle70748-209-07LupinIndia30 January 2026
60 tablet in 1 bottle72205-320-60Novadoz PharmaceuticalsIndia11 September 2026
60 tablet, film coated in 1 bottle60505-3629-6Apotex3 September 2024
60 tablet, film coated in 1 bottle0480-5102-06Teva Pharmaceuticals18 September 2025
60 tablet, film coated in 1 bottle73190-047-60AvKARE18 November 2025
60 tablet, film coated in 1 bottle68001-661-06BluePoint Laboratories30 October 2025
60 tablet, film coated in 1 bottle72603-923-01NorthStar RxLLC1 June 2026
1 bottle in 1 carton / 60 tablet in 1 bottle66993-234-60Prasco Laboratories3 September 2024
60 tablet, film coated in 1 bottle82009-193-60Quallent Pharmaceuticals Health2 November 2026

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 28 June 2006Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Dasatinib 50 mg tablet.

Compare all 2

Other strengths and forms of Dasatinib

Clinical summary

Dasatinib is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Dasatinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Dasatinib

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Dasatinib 50 mg tablet for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.