Orange Book product · Generic (ANDA)
NEOMYCIN AND POLYMYXIN B SULFATE
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
At a glance
Apr 08, 1986
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 08, 1986
40 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Strength
EQ 40MG BASE/ML;200,000 UNITS/ML
Dosage form
SOLUTION
Route
IRRIGATION
TE code
Not listed
Application
ANDA 062664
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- 1985NEOSPORINBrand (NDA)
NDA 050176 · GLAXOSMITHKLINE
- —STATROLBrand (NDA)
NDA 050344 · ALCON
- —STATROLBrand (NDA)
NDA 050456 · ALCON
- 2006NEOMYCIN AND POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 065106 · XGEN PHARMS
- 2006NEOMYCIN AND POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 065108 · XGEN PHARMS
- 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.
