FDA Orange Book · active-ingredient family
Acebutolol hydrochloride
Acebutolol hydrochloride: 1 brand, 3 generics; first approved Dec 28, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
0
Presentations
8
Brand (NDA) products
Originator applications
- SECTRALRLDPROMIUS PHARMANDA 01891719842 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE CAPSULE ORAL Discontinued — EQ 400MG BASE CAPSULE ORAL Discontinued —
Generic (ANDA) products (3)
Abbreviated applications
- ACEBUTOLOL HYDROCHLORIDERSAMNEAL PHARMANDA 07504719992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE CAPSULE ORAL Rx AB EQ 400MG BASE CAPSULE ORAL Rx AB - ACEBUTOLOL HYDROCHLORIDEANI PHARMSANDA 07400719952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE CAPSULE ORAL Rx AB EQ 400MG BASE CAPSULE ORAL Rx AB - ACEBUTOLOL HYDROCHLORIDEPHARMOBEDIENTANDA 07428819952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE CAPSULE ORAL Discontinued — EQ 400MG BASE CAPSULE 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
42 yr 3 mo ago
Most recent approval
27 yr ago
Approvals span 1984–1999 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Acebutolol hydrochloride: 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.
