Orange Book product · Brand (NDA)
DECADRON
DEXAMETHASONE SODIUM PHOSPHATE
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 SODIUM PHOSPHATE
Strength
EQ 24MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 012071
Product number
004
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.
- —DEXACORTBrand (NDA)
NDA 013413 · UCB INC
- —DEXACORTBrand (NDA)
NDA 014242 · UCB INC
- —DECADRONBrand (NDA)
NDA 011983 · MERCK
- —HEXADROLBrand (NDA)
NDA 014694 · ASPEN GLOBAL INC
- —DECADRONBrand (NDA)
NDA 011977 · MERCK
- —DECADRONBrand (NDA)
NDA 011984 · MERCK
- 2024DEXAMETHASONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 217797 · MICRO LABS
- 2023DEXAMETHASONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 211451 · HIKMA
- 2023DEXAMETHASONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 214890 · GENEYORK PHARMS
- 2021DEXAMETHASONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 215654 · GLAND
- 2020DEXAMETHASONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 210966 · EUGIA PHARMA
- 2019DEXAMETHASONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 210967 · EUGIA 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.
