Polymyxin B Sulfate and Trimethoprim
Polymyxin B Sulfate andTrimethoprim Ophthalmic Solution, USPSterile
Approved
Approval ID
cf4bd790-291e-4c35-83bb-205fb06753b6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 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.
polymyxin B sulfate and trimethoprim
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-335
Application NumberANDA064211
Product Classification
M
Marketing Category
C73584
G
Generic Name
polymyxin B sulfate and trimethoprim
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 13, 2006
FDA Product Classification
INGREDIENTS (7)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
polymyxin B sulfateActive
Quantity: 10000 mL in 1 mL
Code: 19371312D4
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Quantity: 0.04 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
sulfuric acidInactive
Code: O40UQP6WCF
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
trimethoprim sulfateActive
Quantity: 1 mg in 1 mL
Code: E377MF8EQ8
Classification: ACTIB