FDA Orange Book · active-ingredient family
Aspirin; pravastatin sodium
Aspirin; pravastatin sodium: 1 brand, 0 generics; first approved Jun 24, 2003.
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
6
Brand (NDA) products
Originator applications
- BRISTOL MYERS SQUIBBNDA 02138720036 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 81MG;20MG TABLET ORAL Discontinued — 81MG;40MG TABLET ORAL Discontinued — 81MG;80MG TABLET ORAL Discontinued — 325MG;20MG TABLET ORAL Discontinued — 325MG;40MG TABLET ORAL Discontinued — 325MG;80MG 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
23 yr 5 mo ago
Most recent approval
23 yr 5 mo ago
All 1 application were approved in 2003.
Brand (NDA) 1100%
Generic (ANDA) 00%
Aspirin; pravastatin sodium: 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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