Orange Book product · Brand (NDA)
PALLADONE
HYDROMORPHONE HYDROCHLORIDE
At a glance
Sep 24, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 24, 2004
22 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROMORPHONE HYDROCHLORIDE
Strength
32MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021044
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2023HYDROMORPHONE HYDROCHLORIDEBrand (NDA)
NDA 217812 · HIKMA
- 2023HYDROMORPHONE HYDROCHLORIDEBrand (NDA)
NDA 200403 · HOSPIRA INC
- 2020DILAUDIDBrand (NDA)
NDA 019034 · FRESENIUS KABI USA
- 2010EXALGOBrand (NDA)
NDA 021217 · SPECGX LLC
- 2007DILAUDIDBrand (NDA)
NDA 019892 · RHODES PHARMS
- 1992DILAUDIDBrand (NDA)
NDA 019891 · RHODES PHARMS
- 2024HYDROMORPHONE HYDROCHLORIDEGeneric (ANDA)
ANDA 216899 · HIKMA
- 2020HYDROMORPHONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212133 · ASCENT PHARMS INC
- 2020HYDROMORPHONE HYDROCHLORIDEGeneric (ANDA)
ANDA 207108 · GENUS
- 2018HYDROMORPHONE HYDROCHLORIDEGeneric (ANDA)
ANDA 202159 · HIKMA
- 2018HYDROMORPHONE HYDROCHLORIDEGeneric (ANDA)
ANDA 210506 · ASCENT PHARMS INC
- 2017HYDROMORPHONE HYDROCHLORIDEGeneric (ANDA)
ANDA 210176 · ASCENT PHARMS INC
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.
