Orange Book product · Generic (ANDA)
DULOXETINE HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE
At a glance
Jan 06, 2017
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 06, 2017
9 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
DULOXETINE HYDROCHLORIDE
Strength
EQ 60MG BASE
Dosage form
CAPSULE, DELAYED REL PELLETS
Route
ORAL
TE code
AB
Application
ANDA 208706
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of DULOXETINE HYDROCHLORIDE
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- 2004CYMBALTABrand (NDA)
NDA 021427 · LILLY
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ANDA 212328 · SUNSHINE
- 2019DULOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207219 · YAOPHARMA CO LTD
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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
- 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.
