Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203563
Company: SANDOZ
Company: SANDOZ
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 | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
03/09/2015 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203563Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203563Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203563Orig1s000TAltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/06/2017 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/09/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203563Orig1s000lbl.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 | 217314 | HAINAN POLY PHARM |
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 |