Orange Book product · Brand (NDA)
DILAUDID-HP
HYDROMORPHONE HYDROCHLORIDE
At a glance
Aug 04, 1994
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 04, 1994
32 yr 4 mo ago
Today
Patent 9731082 expires
Listed drug product patent expiration.
Apr 23, 2032
in 5 yr 11 mo
Patent 9248229 expires
Listed drug product patent expiration.
Mar 12, 2034
in 7 yr 10 mo
Pharmaceutical detail
Active ingredient
HYDROMORPHONE HYDROCHLORIDE
Strength
250MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019034
Product number
002
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
- 2010EXALGOBrand (NDA)
NDA 021217 · SPECGX LLC
- 2007DILAUDIDBrand (NDA)
NDA 019892 · RHODES PHARMS
- 2004PALLADONEBrand (NDA)
NDA 021044 · PURDUE PHARMA LP
- 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 (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9731082 | Apr 23, 2032 | in 5 yr 11 mo | Product |
| 9248229 | Mar 12, 2034 | in 7 yr 10 mo | Product |

