Orange Book product · Brand (NDA)
AZACTAM
AZTREONAM
At a glance
Dec 31, 1986
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 31, 1986
40 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
AZTREONAM
Strength
2GM/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 050580
Product number
003
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.
- 2010CAYSTONBrand (NDA)
NDA 050814 · GILEAD
- 1989AZACTAM IN PLASTIC CONTAINERBrand (NDA)
NDA 050632 · BRISTOL MYERS SQUIBB
- 2026AZTREONAMGeneric (ANDA)
ANDA 207069 · HIKMA
- 2021AZTREONAMGeneric (ANDA)
ANDA 206517 · HOSPIRA
- 2011AZTREONAMGeneric (ANDA)
ANDA 065286 · HIKMA
- 2010AZTREONAMGeneric (ANDA)
ANDA 065439 · FRESENIUS KABI USA
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.
