Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070480
Company: ELKINS SINN
Company: ELKINS SINN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 50MG 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 |
|---|---|---|---|---|---|---|---|
| 01/02/1987 | 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 |
|---|---|---|---|---|---|
| 11/20/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 11/20/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/28/1998 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/10/1997 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/06/1996 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 10/10/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/31/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 09/10/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1990 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 02/26/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/26/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/26/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/13/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 03/28/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |