Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074544
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 25MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 15MG 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 |
|---|---|---|---|---|---|---|---|
| 08/28/1997 | ORIG-1 | Approval |
Label is not available on this site. |
LEUCOVORIN CALCIUM
TABLET;ORAL; EQ 5MG 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 5MG BASE | TABLET;ORAL | Prescription | No | AB | 071198 | BARR |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 074544 | EPIC PHARMA LLC |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 072733 | HIKMA |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 213929 | LEADING |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 211132 | NOVAST LABS |
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 |
TABLET;ORAL; EQ 10MG 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 10MG BASE | TABLET;ORAL | Prescription | No | AB | 074544 | EPIC PHARMA LLC |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 072734 | HIKMA |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 213929 | LEADING |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 211132 | NOVAST LABS |
TABLET;ORAL; EQ 15MG 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 15MG BASE | TABLET;ORAL | Prescription | No | AB | 074544 | EPIC PHARMA LLC |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 072735 | HIKMA |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 213929 | LEADING |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 211132 | NOVAST LABS |