Orange Book product · Brand (NDA)
ZOMETA
ZOLEDRONIC ACID
At a glance
Mar 07, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 07, 2003
23 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
ZOLEDRONIC ACID
Strength
EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 021223
Product number
002
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.
- 2015ZOLEDRONIC ACIDBrand (NDA)
NDA 204016 · HOSPIRA
- 2013ZOLEDRONIC ACIDBrand (NDA)
NDA 203231 · INFORLIFE
- 2007RECLASTBrand (NDA)
NDA 021817 · SANDOZ
- 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.
