FDA Orange Book · active-ingredient family
Levorphanol tartrate
Levorphanol tartrate is approved as 2 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LEVO-DROMORAN · NDA 008720
2
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LEVO-DROMORANRLD | VALEANT PHARM INTL | NDA 008720 | — | Dec 19, 1991 | |
| LEVO-DROMORAN | VALEANT PHARM INTL | NDA 008719 | — | Dec 19, 1991 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LEVORPHANOL TARTRATE×3 | NOVITIUM PHARMA | ANDA 213479 | BX | Jul 20, 2021 | |
| LEVORPHANOL TARTRATE×2 | SUN PHARM INDS INC | ANDA 213906 | AB | Jun 17, 2021 | |
| LEVORPHANOL TARTRATE | SPECGX LLC | ANDA 212024 | AB | Dec 13, 2019 | |
| LEVORPHANOL TARTRATE | ACERTIS PHARMS | ANDA 211484 | AB | Dec 13, 2018 | |
| LEVORPHANOL TARTRATE×3 | HIKMA | ANDA 074278 | — | Jun 18, 2018 |
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.
Levorphanol tartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
