Orange Book product · Generic (ANDA)
ALENDRONATE SODIUM
ALENDRONATE SODIUM
At a glance
May 11, 2023
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 11, 2023
3 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ALENDRONATE SODIUM
Strength
EQ 70MG BASE/75ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 214512
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ALENDRONATE SODIUM
- 2012BINOSTOBrand (NDA)
NDA 202344 · RADIUS
- 2003FOSAMAXBrand (NDA)
NDA 021575 · MERCK
- 1997FOSAMAXBrand (NDA)
NDA 020560 · ORGANON
- 2024ALENDRONATE SODIUMGeneric (ANDA)
ANDA 206387 · IPCA LABS LTD
- 2013ALENDRONATE SODIUMGeneric (ANDA)
ANDA 090520 · HIKMA
- 2010ALENDRONATE SODIUMGeneric (ANDA)
ANDA 090557 · JUBILANT CADISTA
- 2009ALENDRONATE SODIUMGeneric (ANDA)
ANDA 090258 · HANGZHOU BINJIANG
- 2009ALENDRONATE SODIUMGeneric (ANDA)
ANDA 075871 · CHARTWELL RX
- 2008ALENDRONATE SODIUMGeneric (ANDA)
ANDA 090022 · SUN PHARM
- 2008ALENDRONATE SODIUMGeneric (ANDA)
ANDA 077982 · APOTEX
- 2008ALENDRONATE SODIUMGeneric (ANDA)
ANDA 090124 · AUROBINDO PHARMA
- 2008ALENDRONATE SODIUMGeneric (ANDA)
ANDA 079049 · CHARTWELL RX
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.
