Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212735
Company: HIKMA

Products on ANDA 212735

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100%	LIQUID;N/A	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212735

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212735

STERILE WATER FOR INJECTION

LIQUID;N/A; 100%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	100%	LIQUID;N/A	Prescription	Yes	AP	018802	HOSPIRA
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100%	LIQUID;N/A	Prescription	No	AP	209689	FRESENIUS KABI USA
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100%	LIQUID;N/A	Prescription	No	AP	212735	HIKMA
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	100%	LIQUID;N/A	Prescription	Yes	AP	019633	B BRAUN
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	100%	LIQUID;N/A	Prescription	Yes	AP	018632	BAXTER HLTHCARE
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	100%	LIQUID;N/A	Prescription	No	AP	088400	FRESENIUS KABI USA
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	100%	LIQUID;N/A	Prescription	Yes	AP	018233	ICU MEDICAL INC
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	100%	LIQUID;N/A	Prescription	Yes	AP	019869	ICU MEDICAL INC
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	100%	LIQUID;N/A	Prescription	No	AP	077393	TARO