Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089717
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 03/28/1988 | 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 |
|---|---|---|---|---|---|
| 12/18/2019 | SUPPL-31 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/17/2012 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf | |
| 12/04/2000 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/24/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/25/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/02/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/08/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/17/2012 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf |
LEUCOVORIN CALCIUM
INJECTABLE;INJECTION; EQ 100MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 217021 | HAINAN POLY |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 089717 | HIKMA |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216590 | KINDOS |
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203800 | MYLAN LABS LTD |
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200753 | SAGENT PHARMS |