Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071199
Company: BARR
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 25MG BASE | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 09/24/1987 | 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 |
|---|---|---|---|---|---|
| 05/05/2026 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/26/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/16/1999 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/20/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/22/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
LEUCOVORIN CALCIUM
TABLET;ORAL; EQ 25MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 071199 | BARR |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 074544 | EPIC PHARMA LLC |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 072736 | HIKMA |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 211132 | INGENUS PHARMS LLC |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 213929 | LEADING |