An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065185
Company: FRESENIUS KABI USA

Products on ANDA 065185

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065185

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/2008	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
11/08/2011	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
04/25/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065185

BLEOMYCIN SULFATE

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

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

Top