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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211222
Company: NEPHRON

Products on ANDA 211222

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID;N/A	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211222

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/10/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211222

STERILE WATER FOR INJECTION

LIQUID;N/A; 100% (5ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID;N/A	Prescription	No	AP	217341	AM REGENT
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID;N/A	Prescription	No	AP	211188	MEDEFIL INC
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID;N/A	Prescription	No	AP	211222	NEPHRON

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