Orange Book product · Brand (NDA)
ZOLEDRONIC ACID
ZOLEDRONIC ACID
At a glance
Dec 28, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 28, 2015
10 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
ZOLEDRONIC ACID
Strength
EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 204016
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2013ZOLEDRONIC ACIDBrand (NDA)
NDA 203231 · INFORLIFE
- 2007RECLASTBrand (NDA)
NDA 021817 · SANDOZ
- 2001ZOMETABrand (NDA)
NDA 021223 · NOVARTIS
- 2026ZOLEDRONIC ACIDGeneric (ANDA)
ANDA 219984 · GLAND
- 2023ZOLEDRONIC ACIDGeneric (ANDA)
ANDA 213371 · MEITHEAL
- 2020ZOLEDRONIC ACIDGeneric (ANDA)
ANDA 208968 · NOVAST LABS
- 2019ZOLEDRONIC ACIDGeneric (ANDA)
ANDA 209578 · GLAND
- 2019ZOLEDRONIC ACIDGeneric (ANDA)
ANDA 208513 · SHILPA
- 2018ZOLEDRONIC ACIDGeneric (ANDA)
ANDA 204344 · DR REDDYS
- 2018ZOLEDRONICGeneric (ANDA)
ANDA 205749 · GLAND
- 2017ZOLEDRONIC ACIDGeneric (ANDA)
ANDA 207341 · BPI LABS
- 2017ZOLEDRONIC ACIDGeneric (ANDA)
ANDA 209125 · EUGIA PHARMA
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.
