FDA Orange Book · active-ingredient family
Indecainide hydrochloride
Indecainide hydrochloride: 1 brand, 0 generics; first approved Dec 29, 1989.
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
3
Brand (NDA) products
Originator applications
- LILLYNDA 01969319893 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 75MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 100MG BASE TABLET, EXTENDED RELEASE 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
37 yr 1 mo ago
Most recent approval
37 yr 1 mo ago
All 1 application were approved in 1989.
Brand (NDA) 1100%
Generic (ANDA) 00%
Indecainide hydrochloride: 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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