Orange Book product · Generic (ANDA)
ATOMOXETINE HYDROCHLORIDE
ATOMOXETINE HYDROCHLORIDE
At a glance
Feb 18, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 18, 2021
5 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ATOMOXETINE HYDROCHLORIDE
Strength
EQ 10MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 079021
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ATOMOXETINE HYDROCHLORIDE
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- 2002STRATTERABrand (NDA)
NDA 021411 · LILLY
- 2023ATOMOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 079017 · ZYDUS PHARMS USA INC
- 2021ATOMOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202682 · HETERO LABS LTD V
- 2018ATOMOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090609 · DR REDDYS
- 2017ATOMOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 078983 · APOTEX
- 2017ATOMOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 079016 · AUROBINDO PHARMA
- 2017ATOMOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 079019 · GLENMARK PHARMS LTD
- 2017ATOMOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 079022 · TEVA PHARMS USA
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.

