Orange Book product · Brand (NDA)
PENTAM
PENTAMIDINE ISETHIONATE
At a glance
Oct 16, 1984
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 16, 1984
42 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
PENTAMIDINE ISETHIONATE
Strength
300MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 019264
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.
- 1989NEBUPENTBrand (NDA)
NDA 019887 · 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.
