FDA Orange Book · active-ingredient family
Penbutolol sulfate
Penbutolol sulfate: 1 brand, 0 generics; first approved Dec 30, 1987.
Brand onlyHas discontinued products
Generic status & protection
No listed patents or exclusivity: brand product(s) only.
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
0
Presentations
2
Brand (NDA) products
Originator applications
- LEVATOLRLDENDO OPERATIONSNDA 01897619872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG 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
39 yr 2 mo ago
Most recent approval
38 yr 1 mo ago
Approvals span 1987–1989 across 1 FDA application.
Brand (NDA) 1100%
Generic (ANDA) 00%
Penbutolol sulfate: 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
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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.
