Application Nr Approved Date Route Status External Links
ANDA211003 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Levoleucovorin For Injection Is Indicated For: Rescue After High-Dose Methotrexate Therapy In Adult And Pediatric Patients With Osteosarcoma. Diminishing The Toxicity Associated With Overdosage Of Folic Acid Antagonists Or Impaired Methotrexate Elimination In Adult And Pediatric Patients. The Treatment Of Adults With Metastatic Colorectal Cancer In Combination With Fluorouracil. Levoleucovorin For Injection Is A Folate Analog Indicated For: Rescue After High-Dose Methotrexate Therapy In Adult And Pediatric Patients With Osteosarcoma. ( 1 ) Diminishing The Toxicity Associated With Overdosage Of Folic Acid Antagonists Or Impaired Methotrexate Elimination In Adult And Pediatric Patients. ( 1 ) Treatment Of Adults With Metastatic Colorectal Cancer In Combination With Fluorouracil. ( 1 ) Limitations Of Use Levoleucovorin For Injection Is Not Indicated For The Treatment Of Pernicious Anemia And Megaloblastic Anemia Secondary To Lack Of Vitamin B 12 , Because Of The Risk Of Progression Of Neurologic Manifestations Despite Hematologic Remission. ( 1 ) Limitations Of Use Levoleucovorin For Injection Is Not Indicated For Pernicious Anemia And Megaloblastic Anemia Secondary To The Lack Of Vitamin B 12 , Because Of The Risk Of Progression Of Neurologic Manifestations Despite Hematologic Remission.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Levoleucovorin Calcium LEVOLEUCOVORIN CALCIUM ZINC9212427

Comments