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 10MG BASE/ML | INJECTABLE;INJECTION | 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 |
Label is not available on this site. |