Orange Book product · Brand (NDA)
SYNTHROID
LEVOTHYROXINE SODIUM
At a glance
Jul 24, 2002
Approved
Brand (NDA)
Application
AB1,AB2
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 24, 2002
24 yr 3 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
Application
NDA 021402
Product number
001
Marketing status
RX
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.
- 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
- 2002EUTHYROXBrand (NDA)
NDA 021292 · EMD SERONO INC
- 2002LEVO-TBrand (NDA)
NDA 021342 · CEDIPROF INC
- 2001LEVOXYLBrand (NDA)
NDA 021301 · KING PHARMS
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.
