Orange Book product · Brand (NDA)
STRATTERA
ATOMOXETINE HYDROCHLORIDE
At a glance
Feb 14, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 14, 2005
21 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
ATOMOXETINE HYDROCHLORIDE
Strength
EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 021411
Product number
007
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.
- 2026ATONCYBrand (NDA)
NDA 220320 · MAP77
- 2023ATOMOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 079017 · ZYDUS PHARMS USA INC
- 2021ATOMOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202682 · HETERO LABS LTD V
- 2021ATOMOXETINE HYDROCHLORIDEGeneric (ANDA)
ANDA 079021 · STRIDES PHARMA
- 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.
