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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065042
Company: HIKMA

Products on ANDA 065042

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065042

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65042ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/30/2011	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/25/2011	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/05/2007	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065042

BLEOMYCIN SULFATE

INJECTABLE;INJECTION; EQ 30 UNITS BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065185	FRESENIUS KABI USA
BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065042	HIKMA
BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065031	HOSPIRA
BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	EQ 30 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205030	MEITHEAL

INJECTABLE;INJECTION; EQ 15 UNITS BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065185	FRESENIUS KABI USA
BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065042	HIKMA
BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065031	HOSPIRA
BLEOMYCIN SULFATE	BLEOMYCIN SULFATE	EQ 15 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205030	MEITHEAL

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