Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 50MG 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 |
---|---|---|---|---|---|---|---|
09/14/1987 | 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 |
---|---|---|---|---|---|
10/13/2020 | SUPPL-31 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
01/17/2012 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf | |
05/30/2001 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
05/30/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/30/2001 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/04/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/03/1998 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
02/24/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
05/31/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
09/25/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/21/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/02/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
09/02/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/11/1991 | SUPPL-3 | 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-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf |
LEUCOVORIN CALCIUM
INJECTABLE;INJECTION; EQ 50MG 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 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 217021 | HAINAN POLY |
LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 089384 | HIKMA |
LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216590 | MEITHEAL |
LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200753 | SAGENT PHARMS |