Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 081277
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 09/28/1993 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/29/2013 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/16/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/28/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 10/30/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/10/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 05/20/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 07/05/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |