Application Nr Approved Date Route Status External Links
ANDA209151 2017-06-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Anagrelide Is A Platelet Reducing Agent Indicated For The Treatment Of Thrombocythemia, Secondary To Myeloproliferative Neoplasms, To Reduce The Elevated Platelet Count And The Risk Of Thrombosis And To Ameliorate Associated Symptoms Including Thrombo-Hemorrhagic Events. (1) Anagrelide Capsules Are Indicated For The Treatment Of Patients With Thrombocythemia, Secondary To Myeloproliferative Neoplasms, To Reduce The Elevated Platelet Count And The Risk Of Thrombosis And To Ameliorate Associated Symptoms Including Thrombo-Hemorrhagic Events [see Clinical Studies (14), Dosage And Administration (2)].

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Gelatin GELATIN Unresolved
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. 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.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Anagrelide Hydrochloride ANAGRELIDE HYDROCHLORIDE ZINC3871541

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