FDA Orange Book · active-ingredient family
Etidronate disodium
Etidronate disodium: 2 brands, 1 generic; first approved Apr 20, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
2
Generics (ANDA)
1
Listed patents
0
Presentations
5
Brand (NDA) products
Originator applications
- DIDRONELRLDAPILNDA 017831—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — 400MG TABLET ORAL Discontinued — - MGI PHARMA INCNDA 0195451987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (1)
Abbreviated applications
- ETIDRONATE DISODIUMPHARMOBEDIENTANDA 07580020032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — 400MG 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
39 yr 11 mo ago
Most recent approval
23 yr 11 mo ago
Approvals span 1987–2003 across 3 FDA applications.
Brand (NDA) 267%
Generic (ANDA) 133%
Etidronate disodium: 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.
