Orange Book product · Brand (NDA)
NEOSPORIN
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
At a glance
Jan 14, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 14, 1985
42 yr ago
Today
Pharmaceutical detail
Active ingredient
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Strength
EQ 3.5MG BASE/GM;10,000 UNITS/GM
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 050176
Product number
002
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.
- —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
- 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.
