Orange Book product · Generic (ANDA)
ALENDRONATE SODIUM
ALENDRONATE SODIUM
At a glance
Aug 04, 2008
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 04, 2008
18 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ALENDRONATE SODIUM
Strength
EQ 5MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 076584
Product number
001
Marketing status
DISCN
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
- 2023ALENDRONATE SODIUMGeneric (ANDA)
ANDA 214512 · NOVITIUM PHARMA
- 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
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.
