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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075812
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DACARBAZINE DACARBAZINE 200MG/VIAL INJECTABLE;INJECTION Prescription AP No No
DACARBAZINE DACARBAZINE 500MG/VIAL INJECTABLE;INJECTION Prescription AP 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
06/15/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75812ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2002 SUPPL-3 Manufacturing (CMC)-New Strength

Label is not available on this site.

10/31/2002 SUPPL-2 Labeling

Label is not available on this site.

10/31/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

DACARBAZINE

INJECTABLE;INJECTION; 200MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DACARBAZINE DACARBAZINE 200MG/VIAL INJECTABLE;INJECTION Prescription No AP 075371 FRESENIUS KABI USA
DACARBAZINE DACARBAZINE 200MG/VIAL INJECTABLE;INJECTION Prescription No AP 075812 HIKMA
DACARBAZINE DACARBAZINE 200MG/VIAL INJECTABLE;INJECTION Prescription No AP 075940 HOSPIRA
DACARBAZINE DACARBAZINE 200MG/VIAL INJECTABLE;INJECTION Prescription No AP 075259 MEITHEAL

INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DACARBAZINE DACARBAZINE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 075812 HIKMA
DACARBAZINE DACARBAZINE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 075259 MEITHEAL
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