Orange Book product · Generic (ANDA)
RISEDRONATE SODIUM
RISEDRONATE SODIUM
At a glance
Feb 15, 2019
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 15, 2019
7 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
RISEDRONATE SODIUM
Strength
35MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 207516
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of RISEDRONATE SODIUM
- 2010ATELVIABrand (NDA)
NDA 022560 · APIL
- 2000ACTONELBrand (NDA)
NDA 020835 · APIL
- 2019RISEDRONATE SODIUMGeneric (ANDA)
ANDA 203925 · SUN PHARM
- 2019RISEDRONATE SODIUMGeneric (ANDA)
ANDA 205280 · ORBION PHARMS
- 2018RISEDRONATE SODIUMGeneric (ANDA)
ANDA 203822 · ZYDUS PHARMS
- 2018RISEDRONATE SODIUMGeneric (ANDA)
ANDA 205066 · IMPAX LABS INC
- 2016RISEDRONATE SODIUMGeneric (ANDA)
ANDA 206768 · AUROBINDO PHARMA
- 2015RISEDRONATE SODIUMGeneric (ANDA)
ANDA 203533 · MACLEODS PHARMS LTD
- 2015RISEDRONATE SODIUMGeneric (ANDA)
ANDA 090877 · APOTEX
- 2015RISEDRONATE SODIUMGeneric (ANDA)
ANDA 200296 · AUROBINDO PHARMA LTD
- 2015RISEDRONATE SODIUMGeneric (ANDA)
ANDA 200477 · PHARMOBEDIENT
- 2015RISEDRONATE SODIUMGeneric (ANDA)
ANDA 090886 · SUN PHARM
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.
