Orange Book product · Brand (NDA)
BONIVA
IBANDRONATE SODIUM
At a glance
Jan 06, 2006
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 06, 2006
20 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
IBANDRONATE SODIUM
Strength
EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 021858
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2003BONIVABrand (NDA)
NDA 021455 · HOFFMANN LA ROCHE
- 2021IBANDRONATE SODIUMGeneric (ANDA)
ANDA 204329 · NANG KUANG PHARM CO
- 2017IBANDRONATE SODIUMGeneric (ANDA)
ANDA 206887 · MACLEODS PHARMS LTD
- 2016IBANDRONATE SODIUMGeneric (ANDA)
ANDA 204502 · AUROBINDO PHARMA
- 2016IBANDRONATE SODIUMGeneric (ANDA)
ANDA 206058 · ACCORD HLTHCARE
- 2015IBANDRONATE SODIUMGeneric (ANDA)
ANDA 204222 · APOTEX
- 2015IBANDRONATE SODIUMGeneric (ANDA)
ANDA 205332 · EUGIA PHARMA
- 2014IBANDRONATE SODIUMGeneric (ANDA)
ANDA 203987 · AVET LIFESCIENCES
- 2014IBANDRONATE SODIUMGeneric (ANDA)
ANDA 202235 · CHEMI SPA
- 2014IBANDRONATE SODIUMGeneric (ANDA)
ANDA 202671 · PHARMOBEDIENT
- 2014IBANDRONATE SODIUMGeneric (ANDA)
ANDA 090853 · SUN PHARM
- 2012IBANDRONATE SODIUMGeneric (ANDA)
ANDA 078996 · SUN PHARM INDUSTRIES
Listed patents
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.
