Orange Book product · Generic (ANDA)
DEXAMETHASONE
DEXAMETHASONE
At a glance
Oct 05, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 05, 2023
2 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXAMETHASONE
Strength
0.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 215604
Product number
004
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DEXAMETHASONE
- 2018DEXTENZABrand (NDA)
NDA 208742 · OCULAR THERAPEUTIX
- 2018DEXYCU KITBrand (NDA)
NDA 208912 · EYEPOINT PHARMS
- 2009OZURDEXBrand (NDA)
NDA 022315 · ABBVIE
- —DECASPRAYBrand (NDA)
NDA 012731 · MERCK
- —DECADRONBrand (NDA)
NDA 012376 · MERCK
- —HEXADROLBrand (NDA)
NDA 012674 · ASPEN GLOBAL INC
- —DECADERMBrand (NDA)
NDA 013538 · MERCK
- —MAXIDEXBrand (NDA)
NDA 013422 · HARROW EYE
- —DECADRONBrand (NDA)
NDA 011664 · MERCK
- 2024DEXAMETHASONEGeneric (ANDA)
ANDA 218372 · COREPHARMA
- 2023DEXAMETHASONEGeneric (ANDA)
ANDA 217695 · APOTEX
- 2023DEXAMETHASONEGeneric (ANDA)
ANDA 217696 · NOVITIUM 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.
