FDA Orange Book · active-ingredient family
Azithromycin dihydrate; trovafloxacin mesylate
Azithromycin dihydrate; trovafloxacin mesylate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TROVAN/ZITHROMAX COMPLIANCE PAK · NDA 050762
1
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TROVAN/ZITHROMAX COMPLIANCE PAK | PFIZER | NDA 050762 | — | Dec 18, 1998 |
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.
Azithromycin dihydrate; trovafloxacin mesylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
