Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
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
54868-1070Application Number
ANDA062721Marketing Category
ANDA (C73584)Route of Administration
OPHTHALMICEffective Date
June 1, 2012DexamethasoneActive
Code: 7S5I7G3JQLClass: ACTIBQuantity: 1 mg in 1 mL
NeomycinActive
Code: 057Y626693Class: ACTIMQuantity: 3.5 mg in 1 mL
Polymyxin BActive
Code: 19371312D4Class: ACTIMQuantity: 10000 [USP'U] in 1 mL
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT