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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211188
Company: MEDEFIL INC

Products on ANDA 211188

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (1ML)	LIQUID;N/A	Prescription	None	No	No
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (2.5ML)	LIQUID;N/A	Prescription	None	No	Yes
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (3ML)	LIQUID;N/A	Prescription	None	No	Yes
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (5ML)	LIQUID;N/A	Prescription	AP	No	Yes
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID;N/A	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211188

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/02/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2020	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 211188

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

LIQUID;N/A; 100% (10ML)
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% (10ML)	LIQUID;N/A	Prescription	No	AP	217341	AM REGENT
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID;N/A	Prescription	No	AP	206369	HIKMA
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID;N/A	Prescription	Yes	AP	018801	HOSPIRA
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID;N/A	Prescription	No	AP	211188	MEDEFIL INC
STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	100% (10ML)	LIQUID;N/A	Prescription	No	AP	217536	NEXUS

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