Orange Book product · Generic (ANDA)
POLYMYXIN B SULFATE
POLYMYXIN B SULFATE
At a glance
Apr 14, 2016
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 14, 2016
10 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
POLYMYXIN B SULFATE
Strength
EQ 500,000 UNITS BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 207322
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of POLYMYXIN B SULFATE
- 2016POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 206589 · EUGIA PHARMA
- 2014POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 202766 · XELLIA PHARMS APS
- 2011POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 090110 · RISING
- 2008POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 065372 · FRESENIUS KABI USA
- 1994POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 063000 · PHARMOBEDIENT
- 1983POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 062455 · PADDOCK LLC
- —AEROSPORINGeneric (ANDA)
ANDA 062036 · GLAXOSMITHKLINE
- —POLYMYXIN B SULFATEGeneric (ANDA)
ANDA 060716 · HIKMA
- —POLY-RXGeneric (ANDA)
ANDA 061578 · X GEN 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.
