Orange Book product · Generic (ANDA)
DEXAMETHASONE
DEXAMETHASONE
At a glance
Jul 27, 1983
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 27, 1983
43 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXAMETHASONE
Strength
0.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
ELIXIR
Route
ORAL
TE code
Not listed
Application
ANDA 088254
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
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 215604 · NOVITIUM PHARMA
- 2023DEXAMETHASONEGeneric (ANDA)
ANDA 217695 · APOTEX
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.
