Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210892
Company: GLAND PHARMA LTD
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 | 211002 | MEITHEAL |
LEVOLEUCOVORIN CALCIUM | LEVOLEUCOVORIN CALCIUM | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210623 | NOVAST LABS |
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 | 211002 | MEITHEAL |
LEVOLEUCOVORIN CALCIUM | LEVOLEUCOVORIN CALCIUM | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 210623 | NOVAST LABS |
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