Orange Book product · Brand (NDA)
NEBUPENT
PENTAMIDINE ISETHIONATE
At a glance
Jun 15, 1989
Approved
Brand (NDA)
Application
AN
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 15, 1989
37 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
PENTAMIDINE ISETHIONATE
Strength
300MG/VIAL
Dosage form
FOR SOLUTION
Route
INHALATION
TE code
AN
Application
NDA 019887
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 1984PENTAMBrand (NDA)
NDA 019264 · FRESENIUS KABI USA
- 2023PENTAMIDINE ISETHIONATEGeneric (ANDA)
ANDA 206983 · X-GEN PHARMS INC
- 2022PENTAMIDINE ISETHIONATEGeneric (ANDA)
ANDA 206982 · PHARMOBEDIENT
- 2021PENTAMIDINE ISETHIONATEGeneric (ANDA)
ANDA 213806 · AVET LIFESCIENCES
- 2019PENTAMIDINE ISETHIONATEGeneric (ANDA)
ANDA 206667 · PAI HOLDINGS
- 2017PENTAMIDINE ISETHIONATEGeneric (ANDA)
ANDA 206666 · PAI HOLDINGS
- 1995PENTAMIDINE ISETHIONATEGeneric (ANDA)
ANDA 073617 · BAXTER HLTHCARE
- 1995PENTAMIDINE ISETHIONATEGeneric (ANDA)
ANDA 074303 · WATSON LABS
- 1994PENTACARINATGeneric (ANDA)
ANDA 073447 · ARMOUR PHARM
- 1992PENTAMIDINE ISETHIONATEGeneric (ANDA)
ANDA 073479 · HOSPIRA
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.
