Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, USP
Approved
Approval ID
c3b6004a-8cfc-d5f8-e053-2a95a90a3efb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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
NDC Product Code68071-2428
Application NumberANDA064063
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateJune 1, 2021
Generic NameNeomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone
INGREDIENTS (8)
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIM
DEXAMETHASONEActive
Quantity: 1 mg in 1 g
Code: 7S5I7G3JQL
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIM