Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211003
Company: MEITHEAL
Company: MEITHEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVOLEUCOVORIN CALCIUM | LEVOLEUCOVORIN CALCIUM | EQ 50MG BASE/VIAL | POWDER;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 |
|---|---|---|---|---|---|---|---|
| 08/22/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LEVOLEUCOVORIN CALCIUM
POWDER;INTRAVENOUS; EQ 50MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FUSILEV | LEVOLEUCOVORIN CALCIUM | EQ 50MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 020140 | ACROTECH |
| LEVOLEUCOVORIN CALCIUM | LEVOLEUCOVORIN CALCIUM | EQ 50MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 211003 | MEITHEAL |
| LEVOLEUCOVORIN CALCIUM | LEVOLEUCOVORIN CALCIUM | EQ 50MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 206263 | WEST-WARD PHARMS INT |
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