Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bausch & Lomb Incorporated
196603781
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bausch & Lomb Incorporated
Butler Animal Health Supply
Bausch & Lomb Incorporated
807927397
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NEO-POLY-BAC
Product Details
NDC Product Code
11695-1405Application Number
ANDA064064Marketing Category
ANDA (C73584)Route of Administration
OPHTHALMICEffective Date
September 30, 2010BacitracinActive
Code: 89Y4M234ESClass: ACTIBQuantity: 400 [USP'U] in 1 g
Polymyxin BActive
Code: 19371312D4Class: ACTIBQuantity: 10000 [USP'U] in 1 g
NeomycinActive
Code: 057Y626693Class: ACTIBQuantity: 3.5 mg in 1 g
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT