Orange Book product · Brand (NDA)
CYMBALTA
DULOXETINE HYDROCHLORIDE
At a glance
Aug 03, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 03, 2004
22 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
DULOXETINE HYDROCHLORIDE
Strength
EQ 30MG BASE
Dosage form
CAPSULE, DELAYED REL PELLETS
Route
ORAL
TE code
Not listed
Application
NDA 021427
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.
- 2026DULOXETINE HYDROCHLORIDEBrand (NDA)
NDA 219131 · ALMATICA
- 2019DRIZALMA SPRINKLEBrand (NDA)
NDA 212516 · SUN PHARM
- 2021DULOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212328 · SUNSHINE
- 2019DULOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207219 · YAOPHARMA CO LTD
- 2019DULOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210599 · QINGDAO BAHEAL PHARM
- 2018DULOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211310 · CSPC OUYI
- 2017DULOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206653 · PRINSTON INC
- 2017DULOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204815 · MACLEODS PHARMS LTD
- 2017DULOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 208706 · AJANTA PHARMA LTD
- 2016DULOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204343 · HETERO LABS LTD III
- 2015DULOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202336 · INVENTIA
- 2015DULOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090780 · PH HEALTH
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.
