NEO-POLY-DEX
Neomycin and Polymyxin BSulfates and DexamethasoneOphthalmic Ointment USP
Approved
Approval ID
ca8900f2-cf16-425c-91f3-c41f8296358f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2010
Manufacturers
FDA
Butler Animal Health Supply
DUNS: 017880659
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11695-1436
Application NumberANDA064063
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 17, 2010
FDA Product Classification
INGREDIENTS (8)
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIB
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIB
DEXAMETHASONEActive
Quantity: 1 mg in 1 g
Code: 7S5I7G3JQL
Classification: ACTIB
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 8/12/2010
(Sterile)
Rx only