NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP (Sterile)
Approved
Approval ID
e2d2199c-3b8a-4071-9c01-d1e8879f9bff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 9, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6253
Application NumberANDA064047
Product Classification
M
Marketing Category
C73584
G
Generic Name
neomycin sulfate, polymyxin b sulfate and gramicidin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 4, 2011
FDA Product Classification
INGREDIENTS (8)
NEOMYCIN SULFATEActive
Quantity: 1.75 mg in 1 mL
Code: 057Y626693
Classification: ACTIB
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIB
GRAMICIDINActive
Quantity: 0.025 mg in 1 mL
Code: 5IE62321P4
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT