Orange Book product · Brand (NDA)
COLY-MYCIN M
COLISTIMETHATE SODIUM
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
COLISTIMETHATE SODIUM
Strength
EQ 150MG BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 050108
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2015COLISTIMETHATE SODIUMGeneric (ANDA)
ANDA 205356 · XELLIA PHARMS APS
- 2014COLISTIMETHATE SODIUMGeneric (ANDA)
ANDA 201365 · SAGENT PHARMS INC
- 2012COLISTIMETHATE SODIUMGeneric (ANDA)
ANDA 202359 · AVET LIFESCIENCES
- 2008COLISTIMETHATE SODIUMGeneric (ANDA)
ANDA 065364 · FRESENIUS KABI USA
- 2004COLISTIMETHATE SODIUMGeneric (ANDA)
ANDA 065177 · NEXUS
- 1999COLISTIMETHATE SODIUMGeneric (ANDA)
ANDA 064216 · PHARMOBEDIENT
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.
