NPD
Neomycin and Polymyxin BSulfates and DexamethasoneOphthalmic Ointment USP
Approved
Approval ID
2a1d77e9-c706-4d9b-9745-e93ef4919c8a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2010
Manufacturers
FDA
Phoenix Pharmaceutical, Inc.
DUNS: 150711039
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 Code57319-307
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)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIB
DEXAMETHASONEActive
Quantity: 1 mg in 1 g
Code: 7S5I7G3JQL
Classification: ACTIB
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIB
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT