Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207241
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 100MG BASE/10ML (EQ 10MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/14/2018 | ORIG-1 | Approval | STANDARD |
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