Orange Book product · Brand (NDA)
CAYSTON
AZTREONAM
At a glance
Feb 22, 2010
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 22, 2010
16 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
AZTREONAM
Strength
75MG/VIAL
Dosage form
FOR SOLUTION
Route
INHALATION
TE code
Not listed
Application
NDA 050814
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.
- 1989AZACTAM IN PLASTIC CONTAINERBrand (NDA)
NDA 050632 · BRISTOL MYERS SQUIBB
- 1986AZACTAMBrand (NDA)
NDA 050580 · LABS DELBERT
- 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.
