FDA Orange Book · active-ingredient family
Bretylium tosylate
Bretylium tosylate: 7 brands, 10 generics; first approved Apr 29, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 10 ANDA applications approved.
Brands (NDA)
7
Generics (ANDA)
10
Listed patents
0
Presentations
24
Brand (NDA) products
Originator applications
- BRETYLIUM TOSYLATERLDHOSPIRANDA 0190301986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - BAXTER HLTHCARENDA 01983719892 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG/100ML INJECTABLE INJECTION Discontinued — 200MG/100ML INJECTABLE INJECTION Discontinued — - BRETYLIUM TOSYLATEHOSPIRANDA 0190331986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - ABBOTTNDA 01900519863 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 800MG/100ML INJECTABLE INJECTION Discontinued — 200MG/100ML INJECTABLE INJECTION Discontinued — 400MG/100ML INJECTABLE INJECTION Discontinued — - B BRAUNNDA 01912119863 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/100ML INJECTABLE INJECTION Discontinued — 200MG/100ML INJECTABLE INJECTION Discontinued — 400MG/100ML INJECTABLE INJECTION Discontinued — - HOSPIRA INCNDA 01900819863 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 800MG/100ML INJECTABLE INJECTION Discontinued — 200MG/100ML INJECTABLE INJECTION Discontinued — 400MG/100ML INJECTABLE INJECTION Discontinued — - HOSPIRANDA 017954—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (10)
Abbreviated applications
- BRETYLIUM TOSYLATEBRECKENRIDGEANDA 2043862018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - BRETYLIUM TOSYLATELUITPOLDANDA 0708911988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - BRETYLIUM TOSYLATEASTRAZENECAANDA 0711511987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - BRETYLIUM TOSYLATEASTRAZENECAANDA 0711521987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - BRETYLIUM TOSYLATEASTRAZENECAANDA 0711531987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - BRETYLIUM TOSYLATEABRAXIS PHARMANDA 0712981987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - BRETYLIUM TOSYLATEHIKMAANDA 0705451986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - BRETYLIUM TOSYLATEHIKMAANDA 0705461986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - BRETYLIUM TOSYLATEABRAXIS PHARMANDA 0701341986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - BRETYLIUM TOSYLATEINTL MEDICATIONANDA 0701191986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION 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
40 yr 11 mo ago
Most recent approval
7 yr 10 mo ago
Approvals span 1986–2018 across 17 FDA applications.
Brand (NDA) 741%
Generic (ANDA) 1059%
Bretylium tosylate: 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.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 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.
