Neomycin and Polymyxin B Sulfates and Gramicidin
Neomycin and Polymyxin B Sulfatesand Gramicidin Ophthalmic Solution USP
Approved
Approval ID
65edc059-0806-4625-b583-0e36f04cf085
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Gramicidin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-528
Application NumberANDA064047
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin sulfate, Polymyxin B Sulfate and Gramicidin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 22, 2007
FDA Product Classification
INGREDIENTS (12)
Neomycin SulfateActive
Quantity: 1.75 mg in 1 mL
Code: 057Y626693
Classification: ACTIB
Polymyxin B SulfateActive
Quantity: 10000 mg in 1 mL
Code: 19371312D4
Classification: ACTIB
GramicidinActive
Quantity: 0.025 mg in 1 mL
Code: 5IE62321P4
Classification: ACTIB
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
ThimerosalInactive
Code: 2225PI3MOV
Classification: IACT