Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic SuspensionSterile Rx Only
Approved
Approval ID
cf1a6da8-ba79-4bff-a13b-6effb67f6c1c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2021
Manufacturers
FDA
Sandoz Inc.
DUNS: 005387188
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 Code61314-630
Application NumberANDA062341
Product Classification
M
Marketing Category
C73584
G
Generic Name
neomycin sulfate, polymyxin b sulfate and dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 16, 2011
FDA Product Classification
INGREDIENTS (10)
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 mL
Code: 057Y626693
Classification: ACTIM
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIM
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT