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FDA Orange Book · active-ingredient family

Oxyphenbutazone

Oxyphenbutazone: 1 brand, 1 generic; first approved Sep 03, 1982; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available — 1 ANDA application approved.

Brands (NDA)
1
Generics (ANDA)
1
Listed patents
0
Presentations
2
Originator applications

Brand (NDA) products

TANDEARIL
NDA 0125421982
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
100MGTABLETORALDiscontinued—
Abbreviated applications

Generic (ANDA) products (1)

OXYPHENBUTAZONE
ANDA 0883991984
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
100MGTABLETORALDiscontinued—
Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval
Sep 03, 1982
44 yr 6 mo ago
Most recent approval
Sep 17, 1984
42 yr 5 mo ago

Approvals span 1982–1984 across 2 FDA applications.

Brand (NDA) 150%
Generic (ANDA) 150%

Oxyphenbutazone — 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.

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