Orange Book product · Brand (NDA)
STATROL
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Strength
EQ 3.5MG BASE/ML;16,250 UNITS/ML
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 050456
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1985NEOSPORINBrand (NDA)
NDA 050176 · GLAXOSMITHKLINE
- —STATROLBrand (NDA)
NDA 050344 · ALCON
- 2006NEOMYCIN AND POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 065106 · XGEN PHARMS
- 2006NEOMYCIN AND POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 065108 · XGEN PHARMS
- 1986NEOMYCIN AND POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 062664 · WATSON LABS
- 1984STATROLGeneric (ANDA)
ANDA 062339 · ALCON
- —NEOSPORIN G.U. IRRIGANTGeneric (ANDA)
ANDA 060707 · MONARCH PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
