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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089717
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 MEITHEAL
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
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