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Bacteriostatic Water

BACTERIOSTATIC WATER

Approved
Approval ID

ccadcf46-6a6f-436b-9bbc-17e2983a335f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 7, 2014

Manufacturers
FDA

US MedSource, LLC

DUNS: 032793851

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

WATER

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61699-3977
Application NumberNDA018802
Product Classification
M
Marketing Category
C73594
G
Generic Name
WATER
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateJuly 7, 2014
FDA Product Classification

INGREDIENTS (2)

WATERActive
Quantity: 1 mL in 1 mL
Code: 059QF0KO0R
Classification: ACTIB
BENZYL ALCOHOLInactive
Quantity: 9 mg in 1 mL
Code: LKG8494WBH
Classification: IACT

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Bacteriostatic Water - FDA Drug Approval Details