Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210892
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Prescription AP No No
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/14/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210892Orig1s000ltr.pdf

LEVOLEUCOVORIN CALCIUM

SOLUTION;INTRAVENOUS; EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 207548 AMNEAL
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 210892 GLAND PHARMA LTD
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 210623 INGENUS PHARMS LLC
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 211002 MEITHEAL
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 203563 SANDOZ INC

SOLUTION;INTRAVENOUS; EQ 250MG BASE/25ML (EQ 10MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 210892 GLAND PHARMA LTD
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 210623 INGENUS PHARMS LLC
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 211002 MEITHEAL

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