Orange Book product · Brand (NDA)
FOSAMAX
ALENDRONATE SODIUM
At a glance
Apr 25, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 25, 1997
29 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
ALENDRONATE SODIUM
Strength
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020560
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2012BINOSTOBrand (NDA)
NDA 202344 · RADIUS
- 2003FOSAMAXBrand (NDA)
NDA 021575 · MERCK
- 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
- 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.
