Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207069
Company: HIKMA

Products on ANDA 207069

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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 207069

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/05/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207069

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	207069	HIKMA
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	207069	HIKMA
AZTREONAM	AZTREONAM	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206517	HOSPIRA