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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065439
Company: FRESENIUS KABI USA

Products on ANDA 065439

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZTREONAM	AZTREONAM	500MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
AZTREONAM	AZTREONAM	1GM/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
AZTREONAM	AZTREONAM	2GM/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065439

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/18/2010	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/065439Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/29/2021	SUPPL-14	Labeling-Patient Package Insert		Label is not available on this site.
11/29/2021	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
04/28/2015	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/28/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065439

AZTREONAM

INJECTABLE;INJECTION; 1GM/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZACTAM	AZTREONAM	1GM/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050580	BRISTOL MYERS SQUIBB
AZTREONAM	AZTREONAM	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065439	FRESENIUS KABI USA
AZTREONAM	AZTREONAM	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206517	HOSPIRA

INJECTABLE;INJECTION; 2GM/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZACTAM	AZTREONAM	2GM/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050580	BRISTOL MYERS SQUIBB
AZTREONAM	AZTREONAM	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065439	FRESENIUS KABI USA
AZTREONAM	AZTREONAM	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206517	HOSPIRA

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