Orange Book product · Brand (NDA)
DECASPRAY
DEXAMETHASONE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
DEXAMETHASONE
Strength
0.04% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
AEROSOL
Route
TOPICAL
TE code
Not listed
Application
NDA 012731
Product number
002
Marketing status
DISCN
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.
- 2018DEXTENZABrand (NDA)
NDA 208742 · OCULAR THERAPEUTIX
- 2018DEXYCU KITBrand (NDA)
NDA 208912 · EYEPOINT PHARMS
- 2009OZURDEXBrand (NDA)
NDA 022315 · ABBVIE
- —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
- 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.
