Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040056
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 200MG 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 |
---|---|---|---|---|---|---|---|
05/23/1995 | 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 |
---|---|---|---|---|---|
01/17/2012 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf | |
12/21/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/03/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
02/24/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
05/31/1996 | SUPPL-1 | Labeling |
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-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf |
LEUCOVORIN CALCIUM PRESERVATIVE FREE
INJECTABLE;INJECTION; EQ 200MG 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 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 217021 | HAINAN POLY |
LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216590 | KINDOS |
LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040258 | FRESENIUS KABI USA |
LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040056 | HIKMA |
LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203800 | MYLAN LABS LTD |
LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200753 | SAGENT PHARMS |