Neomycin Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP (Sterile)
Approved
Approval ID
548089f3-29d8-4ba8-af21-9e04356ac29c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code63187-498
Application NumberANDA064135
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 1, 2022
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
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT