Orange Book product · Generic (ANDA)
LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM
At a glance
Oct 19, 2020
Approved
Generic (ANDA)
Application
AB1,AB2,AB3,AB4
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 19, 2020
5 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOTHYROXINE SODIUM
Strength
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
TE code
AB1,AB2,AB3,AB4
Application
ANDA 212399
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LEVOTHYROXINE SODIUM
- 2022ERMEZABrand (NDA)
NDA 215809 · MYLAN
- 2021LEVOTHYROXINE SODIUMBrand (NDA)
NDA 214253 · HIKMA
- 2020THYQUIDITYBrand (NDA)
NDA 214047 · STEVENS J
- 2019LEVOTHYROXINE SODIUMBrand (NDA)
NDA 210632 · FRESENIUS KABI USA
- 2016TIROSINT-SOLBrand (NDA)
NDA 206977 · IBSA
- 2011LEVOTHYROXINE SODIUMBrand (NDA)
NDA 202231 · FRESENIUS KABI USA
- 2007TIROSINTBrand (NDA)
NDA 021924 · IBSA
- 2003LEVOLETBrand (NDA)
NDA 021137 · GENUS LIFESCIENCES
- 2002THYRO-TABSBrand (NDA)
NDA 021116 · ALVOGEN
- 2002SYNTHROIDBrand (NDA)
NDA 021402 · ABBVIE
- 2002EUTHYROXBrand (NDA)
NDA 021292 · EMD SERONO INC
- 2002LEVO-TBrand (NDA)
NDA 021342 · CEDIPROF INC
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.
