Orange Book product · Generic (ANDA)
RISEDRONATE SODIUM
RISEDRONATE SODIUM
At a glance
Dec 09, 2015
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 09, 2015
10 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
RISEDRONATE SODIUM
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 203533
Product number
001
Marketing status
RX
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
- 2019RISEDRONATE SODIUMGeneric (ANDA)
ANDA 207516 · HANGZHOU BINJIANG
- 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 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.
