FDA Orange Book · active-ingredient family
Aspirin; butalbital
Aspirin; butalbital: 0 brands, 1 generic; first approved Oct 13, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
0
Generics (ANDA)
1
Listed patents
0
Presentations
1
Generic (ANDA) products (1)
Abbreviated applications
- SAVAGE LABSANDA 0883051983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG;50MG 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
43 yr 5 mo ago
Most recent approval
43 yr 5 mo ago
All 1 application were approved in 1983.
Brand (NDA) 00%
Generic (ANDA) 1100%
Aspirin; butalbital: 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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