Orange Book product · Generic (ANDA)
ZOLEDRONIC ACID
ZOLEDRONIC ACID
At a glance
Mar 04, 2013
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 04, 2013
13 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
ZOLEDRONIC ACID
Strength
EQ 4MG BASE/5ML
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
ANDA 091186
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of ZOLEDRONIC ACID
- 2015ZOLEDRONIC ACIDBrand (NDA)
NDA 204016 · HOSPIRA
- 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
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.
