NDC 11695-1403

NEO-POLY-DEX

Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone

NEO-POLY-DEX is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Butler Animal Health Supply. The primary component is Neomycin Sulfate; Polymyxin B Sulfate; Dexamethasone.

Product ID11695-1403_bf900a90-9ece-4bbb-9a72-6f7e5c04e202
NDC11695-1403
Product TypeHuman Prescription Drug
Proprietary NameNEO-POLY-DEX
Generic NameNeomycin Sulfate, Polymyxin B Sulfate And Dexamethasone
Dosage FormSuspension/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date1995-09-13
Marketing CategoryANDA / ANDA
Application NumberANDA064135
Labeler NameButler Animal Health Supply
Substance NameNEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
Active Ingredient Strength4 mg/mL; [USP'U]/mL; mg/mL
Pharm ClassesPolymyxin-class Antibacterial [EPC],Polymyxins [CS],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 11695-1403-5

1 BOTTLE, DROPPER in 1 CARTON (11695-1403-5) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date1995-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11695-1403-5 [11695140305]

NEO-POLY-DEX SUSPENSION/ DROPS
Marketing CategoryANDA
Application NumberANDA064135
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1995-09-13
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
NEOMYCIN SULFATE3.5 mg/mL

Pharmacological Class

  • Polymyxin-class Antibacterial [EPC]
  • Polymyxins [CS]
  • Aminoglycoside Antibacterial [EPC]
  • Aminoglycosides [CS]
  • Corticosteroid [EPC]
  • Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "NEO-POLY-DEX" or generic name "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone"

NDCBrand NameGeneric Name
11695-1403NEO-POLY-DEXNeomycin sulfate, Polymyxin B Sulfate and Dexamethasone
11695-1436NEO-POLY-DEXNeomycin sulfate, Polymyxin B Sulfate, and Dexamethasone
0065-0631MAXITROLneomycin sulfate, polymyxin b sulfate and dexamethasone
0078-0771MAXITROLneomycin sulfate, polymyxin b sulfate and dexamethasone
0078-0792Maxitrolneomycin sulfate, polymyxin b sulfate and dexamethasone
0998-0630Maxitrolneomycin sulfate, polymyxin b sulfate and dexamethasone
21695-595Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin B sulfate and dexamethasone
33261-551Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
49999-141Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
50090-1957Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
50090-3068Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
53002-9511Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
61314-630Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
68071-3359Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
68788-7686Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
68788-9120Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
13985-028Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and Dexamethasone
24208-830Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and Dexamethasone
45865-796Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and Dexamethasone
50090-0570Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and Dexamethasone
52959-085Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and Dexamethasone
53002-9510Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and Dexamethasone
57319-347Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and Dexamethasone
63187-498Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and Dexamethasone
66267-958Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and Dexamethasone
68071-4375Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and Dexamethasone
68788-9702Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and Dexamethasone

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.