Orange Book product · Brand (NDA)
FOSRENOL
LANTHANUM CARBONATE
At a glance
Nov 23, 2005
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 23, 2005
20 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
LANTHANUM CARBONATE
Strength
EQ 1GM BASE
Dosage form
TABLET, CHEWABLE
Route
ORAL
TE code
AB
Application
NDA 021468
Product number
004
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2014FOSRENOLBrand (NDA)
NDA 204734 · TAKEDA PHARMS USA
- 2025LANTHANUM CARBONATEGeneric (ANDA)
ANDA 202329 · ALKEM LABS LTD
- 2022LANTHANUM CARBONATEGeneric (ANDA)
ANDA 090977 · BARR
- 2022LANTHANUM CARBONATEGeneric (ANDA)
ANDA 206868 · INVAGEN PHARMS
- 2017LANTHANUM CARBONATEGeneric (ANDA)
ANDA 090978 · NATCO PHARMA LTD
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.
