Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072736
Company: HIKMA
Company: HIKMA
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 | 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 |
---|---|---|---|---|---|---|---|
02/22/1993 | 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 |
---|---|---|---|---|---|
11/07/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/22/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/07/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
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08/28/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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11/04/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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11/04/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
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11/04/1994 | SUPPL-1 | 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 | 213929 | LEADING |
LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 211132 | NOVAST LABS |