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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075812
Company: HIKMA

Products on ANDA 075812

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075812

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.

Therapeutic Equivalents for ANDA 075812

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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