FDA Orange Book · active-ingredient family
Alendronate sodium; cholecalciferol
Alendronate sodium; cholecalciferol: 1 brand, 0 generics; first approved Apr 07, 2005.
Brand only
Generic status & protection
No listed patents or exclusivity: brand product(s) only.
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
0
Presentations
2
Brand (NDA) products
Originator applications
- ORGANON LLCNDA 02176220052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 70MG BASE;2,800 IU TABLET ORAL Rx — EQ 70MG BASE;5,600 IU TABLET ORAL Rx —
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 7 mo ago
Most recent approval
19 yr 6 mo ago
Approvals span 2005–2007 across 1 FDA application.
Brand (NDA) 1100%
Generic (ANDA) 00%
Alendronate sodium; cholecalciferol: 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
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- 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.
