Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aidarex Pharmaceuticals
Aidarex Pharmaceuticals LLC
801503249
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Neomycin and Polymyxin B Sulfates and Dexamethasone
Product Details
NDC Product Code
33261-551Application Number
ANDA062341Marketing Category
ANDA (C73584)Route of Administration
OPHTHALMICEffective Date
August 14, 2018WATERInactive
Code: 059QF0KO0RClass: IACT
NeomycinActive
Code: 057Y626693Class: ACTIMQuantity: 3.5 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACT
Polymyxin BActive
Code: 19371312D4Class: ACTIMQuantity: 10000 [USP'U] in 1 mL
DexamethasoneActive
Code: 7S5I7G3JQLClass: ACTIBQuantity: 1 mg in 1 mL
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35Class: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT