FDA Orange Book · active-ingredient family
Calcium carbonate; risedronate sodium
Calcium carbonate; risedronate sodium: 1 brand, 0 generics; first approved Aug 12, 2005.
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
1
Brand (NDA) products
Originator applications
- WARNER CHILCOTTNDA 0218232005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE;35MG 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
21 yr 3 mo ago
Most recent approval
21 yr 3 mo ago
All 1 application were approved in 2005.
Brand (NDA) 1100%
Generic (ANDA) 00%
Calcium carbonate; risedronate 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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