Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 60MG BASE/VIAL | FOR SOLUTION;ORAL | Discontinued | None | No | No |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 350MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/20/1952 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/17/2003 | SUPPL-55 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08-107scm055ltr.pdf |
| 02/12/2002 | SUPPL-54 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08107s54ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/08107s054_LeucovorinTOC.cfm |
| 11/08/1999 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1997 | SUPPL-51 | Labeling |
Label is not available on this site. |
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| 05/24/1996 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 01/26/1996 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/15/1992 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 09/11/1990 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/23/1989 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/10/1992 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/12/1991 | SUPPL-40 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/31/1988 | SUPPL-39 | Efficacy-New Indication |
Label is not available on this site. |
||
| 04/05/1989 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/1988 | SUPPL-36 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/30/1988 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 01/30/1987 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 01/30/1987 | SUPPL-33 | Efficacy-New Route Of Administration |
Label is not available on this site. |
||
| 01/30/1987 | SUPPL-32 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 06/28/1984 | SUPPL-31 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/22/1984 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/1983 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/27/1981 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 01/27/1981 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1980 | SUPPL-25 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/19/1980 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/04/1980 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1980 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/16/1980 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/1980 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1979 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/07/1979 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/06/1979 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1979 | SUPPL-16 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/09/1979 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/11/1977 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/15/1977 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |