Application Nr Approved Date Route Status External Links
ANDA078340 2015-12-03 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Imatinib Mesylate Is A Kinase Inhibitor Indicated For The Treatment Of: Newly Diagnosed Adult And Pediatric Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia (ph+ Cml) In Chronic Phase (1.1) Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia (ph+ Cml) In Blast Crisis (bc), Accelerated Phase (ap), Or In Chronic Phase (cp) After Failure Of Interferon-Alpha Therapy (1.2) Adult Patients With Relapsed Or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ph+ All) (1.3) Adult Patients With Myelodysplastic/myeloproliferative Diseases (mds/mpd) Associated With Pdgfr (platelet-Derived Growth Factor Receptor) Gene Re-Arrangements As Determined With An Fda-Approved Test (1.5) Adult Patients With Aggressive Systemic Mastocytosis (asm) Without The D816v C-Kit Mutation As Determined With An Fda-Approved Test Or With C-Kit Mutational Status Unknown (1.6) Adult Patients With Hypereosinophilic Syndrome (hes) And/or Chronic Eosinophilic Leukemia (cel) Who Have The Fip1l1-Pdgfrα Fusion Kinase (mutational Analysis Or Fish Demonstration Of Chic2 Allele Deletion) And For Patients With Hes And/or Cel Who Are Fip1l1­-Pdgfrα Fusion Kinase Negative Or Unknown (1.7) Adult Patients With Unresectable, Recurrent And/or Metastatic Dermatofibrosarcoma Protuberans (dfsp) (1.8) 1.1 Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (ph+ Cml) Newly Diagnosed Adult And Pediatric Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia (ph+ Cml) In Chronic Phase. 1.2 Ph+ Cml In Blast Crisis (bc), Accelerated Phase (ap) Or Chronic Phase (cp) After Interferon-Alpha (ifn) Therapy Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia In Blast Crisis, Accelerated Phase, Or In Chronic Phase After Failure Of Interferon-Alpha Therapy. 1.3 Adult Patients With Ph+ Acute Lymphoblastic Leukemia (all) Adult Patients With Relapsed Or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ph+ All). 1.5 Myelodysplastic/myeloproliferative Diseases (mds/mpd) Adult Patients With Myelodysplastic/myeloproliferative Diseases Associated With Pdgfr (platelet-Derived Growth Factor Receptor) Gene Re-Arrangements As Determined With An Fda-Approved Test [see Dosage And Administration (2.6)]. 1.6 Aggressive Systemic Mastocytosis (asm) Adult Patients With Aggressive Systemic Mastocytosis Without The D816v C-Kit Mutation As Determined With An Fda-Approved Test [see Dosage And Administration (2.7)] Or With C-Kit Mutational Status Unknown. 1.7 Hypereosinophilic Syndrome (hes) And/or Chronic Eosinophilic Leukemia (cel) Adult Patients With Hypereosinophilic Syndrome And/or Chronic Eosinophilic Leukemia Who Have The Fip1l1­-Pdgfrα Fusion Kinase (mutational Analysis Or Fish Demonstration Of Chic2 Allele Deletion) And For Patients With Hes And/or Cel Who Are Fip1l1-Pdgfrα Fusion Kinase Negative Or Unknown. 1.8 Dermatofibrosarcoma Protuberans (dfsp) Adult Patients With Unresectable, Recurrent And/or Metastatic Dermatofibrosarcoma Protuberans.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
2. Copovidone K25-31 COPOVIDONE K25-31 Unresolved
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Hypromelloses HYPROMELLOSES Unresolved
5. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Imatinib Mesylate IMATINIB MESYLATE ZINC19632618

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