Orange Book product · Generic (ANDA)
IBANDRONATE SODIUM
IBANDRONATE SODIUM
At a glance
Feb 05, 2016
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 05, 2016
10 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
IBANDRONATE SODIUM
Strength
EQ 3MG BASE/3ML
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
ANDA 206058
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of IBANDRONATE SODIUM
- 2006BONIVABrand (NDA)
NDA 021858 · ROCHE
- 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
- 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.

