FDA Orange Book · active-ingredient family
Levorphanol tartrate
Levorphanol tartrate: 2 brands, 5 generics; first approved Dec 19, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
5
Listed patents
0
Presentations
12
Brand (NDA) products
Originator applications
- VALEANT PHARM INTLNDA 0087201991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — - VALEANT PHARM INTLNDA 0087191991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (5)
Abbreviated applications
- LEVORPHANOL TARTRATENOVITIUM PHARMAANDA 21347920213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx BX 3MG TABLET ORAL Rx BX 1MG TABLET ORAL Rx BX - LEVORPHANOL TARTRATESUN PHARM INDS INCANDA 21390620212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 3MG TABLET ORAL Rx — - LEVORPHANOL TARTRATESPECGX LLCANDA 2120242019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB - LEVORPHANOL TARTRATEACERTIS PHARMSANDA 2114842018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB - LEVORPHANOL TARTRATEHIKMAANDA 07427820183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 1MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
35 yr 4 mo ago
Most recent approval
3 yr 6 mo ago
Approvals span 1991–2023 across 7 FDA applications.
Brand (NDA) 229%
Generic (ANDA) 571%
Levorphanol tartrate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
