Orange Book product · Brand (NDA)
TROVAN/ZITHROMAX COMPLIANCE PAK
AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE
At a glance
Dec 18, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 18, 1998
27 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE
Strength
EQ 1GM BASE,N/A;N/A,EQ 100MG BASE
Dosage form
FOR SUSPENSION, TABLET
Route
ORAL
TE code
Not listed
Application
NDA 050762
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active 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.
