Orange Book product · Brand (NDA)
AZACTAM IN PLASTIC CONTAINER
AZTREONAM
Brand (NDA)NDA 050632DISCN BRISTOL MYERS SQUIBB
At a glance
May 24, 1989
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 24, 1989
37 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
AZTREONAM
Strength
40MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 050632
Product number
001
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.
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.
