Orange Book product · Brand (NDA)
ZOMETA
ZOLEDRONIC ACID
At a glance
Jun 17, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 17, 2011
15 yr 3 mo ago
Today
Patent 7932241 expires
Listed drug product patent expiration.
Feb 05, 2028
in 1 yr 8 mo
Pharmaceutical detail
Active ingredient
ZOLEDRONIC ACID
Strength
EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
003
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 (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7932241 | Feb 05, 2028 | in 1 yr 8 mo | Product |
