FDA Orange Book · active-ingredient family
Pyrazinamide
Pyrazinamide is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PYRAZINAMIDE | MACLEODS PHARMS LTD | ANDA 212541 | AB | Jul 27, 2020 | |
| PYRAZINAMIDE | HIKMA | ANDA 081319 | AB | Jun 30, 1992 | |
| PYRAZINAMIDERLD | NOVITIUM PHARMA | ANDA 080157 | AB | Approved Prior to Jan 1, 1982 |
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.
Pyrazinamide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

