FDA Orange Book · active-ingredient family
Atomoxetine hydrochloride
Atomoxetine hydrochloride: 2 brands, 9 generics; first approved Nov 26, 2002; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
9
Listed patents
0
Presentations
72
Brand (NDA) products
Originator applications
- MAP77NDA 2203202026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/ML SOLUTION ORAL Rx — - STRATTERARLDLILLYNDA 02141120028 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE CAPSULE ORAL Discontinued — EQ 10MG BASE CAPSULE ORAL Discontinued — EQ 18MG BASE CAPSULE ORAL Discontinued — EQ 25MG BASE CAPSULE ORAL Discontinued — EQ 40MG BASE CAPSULE ORAL Discontinued — EQ 60MG BASE CAPSULE ORAL Discontinued — EQ 80MG BASE CAPSULE ORAL Discontinued — EQ 100MG BASE CAPSULE ORAL Discontinued —
Generic (ANDA) products (9)
Abbreviated applications
- ATOMOXETINE HYDROCHLORIDECREEKWOOD PHARMSANDA 21887520267 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB EQ 18MG BASE CAPSULE ORAL Rx AB EQ 25MG BASE CAPSULE ORAL Rx AB EQ 40MG BASE CAPSULE ORAL Rx AB EQ 60MG BASE CAPSULE ORAL Rx AB EQ 80MG BASE CAPSULE ORAL Rx AB EQ 100MG BASE CAPSULE ORAL Rx AB - ATOMOXETINE HYDROCHLORIDEZYDUS PHARMS USA INCANDA 07901720237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 18MG BASE CAPSULE ORAL Rx AB EQ 25MG BASE CAPSULE ORAL Rx AB EQ 40MG BASE CAPSULE ORAL Rx AB EQ 60MG BASE CAPSULE ORAL Rx AB EQ 80MG BASE CAPSULE ORAL Rx AB EQ 100MG BASE CAPSULE ORAL Rx AB EQ 10MG BASE CAPSULE ORAL Rx AB - ATOMOXETINE HYDROCHLORIDEHETERO LABS LTD VANDA 20268220217 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB EQ 18MG BASE CAPSULE ORAL Rx AB EQ 25MG BASE CAPSULE ORAL Rx AB EQ 40MG BASE CAPSULE ORAL Rx AB EQ 60MG BASE CAPSULE ORAL Rx AB EQ 80MG BASE CAPSULE ORAL Rx AB EQ 100MG BASE CAPSULE ORAL Rx AB - ATOMOXETINE HYDROCHLORIDESTRIDES PHARMAANDA 07902120217 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB EQ 18MG BASE CAPSULE ORAL Rx AB EQ 25MG BASE CAPSULE ORAL Rx AB EQ 40MG BASE CAPSULE ORAL Rx AB EQ 60MG BASE CAPSULE ORAL Rx AB EQ 80MG BASE CAPSULE ORAL Rx AB EQ 100MG BASE CAPSULE ORAL Rx AB - ATOMOXETINE HYDROCHLORIDEDR REDDYSANDA 09060920187 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB EQ 18MG BASE CAPSULE ORAL Rx AB EQ 25MG BASE CAPSULE ORAL Rx AB EQ 40MG BASE CAPSULE ORAL Rx AB EQ 60MG BASE CAPSULE ORAL Rx AB EQ 80MG BASE CAPSULE ORAL Rx AB EQ 100MG BASE CAPSULE ORAL Rx AB - ATOMOXETINE HYDROCHLORIDEAPOTEXANDA 07898320177 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB EQ 18MG BASE CAPSULE ORAL Rx AB EQ 25MG BASE CAPSULE ORAL Rx AB EQ 40MG BASE CAPSULE ORAL Rx AB EQ 60MG BASE CAPSULE ORAL Rx AB EQ 80MG BASE CAPSULE ORAL Rx AB EQ 100MG BASE CAPSULE ORAL Rx AB - ATOMOXETINE HYDROCHLORIDEAUROBINDO PHARMAANDA 07901620177 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB EQ 18MG BASE CAPSULE ORAL Rx AB EQ 25MG BASE CAPSULE ORAL Rx AB EQ 40MG BASE CAPSULE ORAL Rx AB EQ 60MG BASE CAPSULE ORAL Rx AB EQ 80MG BASE CAPSULE ORAL Rx AB EQ 100MG BASE CAPSULE ORAL Rx AB - ATOMOXETINE HYDROCHLORIDEGLENMARK PHARMS LTDANDA 07901920177 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB EQ 18MG BASE CAPSULE ORAL Rx AB EQ 25MG BASE CAPSULE ORAL Rx AB EQ 40MG BASE CAPSULE ORAL Rx AB EQ 60MG BASE CAPSULE ORAL Rx AB EQ 80MG BASE CAPSULE ORAL Rx AB EQ 100MG BASE CAPSULE ORAL Rx AB - ATOMOXETINE HYDROCHLORIDETEVA PHARMS USAANDA 07902220177 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB EQ 18MG BASE CAPSULE ORAL Rx AB EQ 25MG BASE CAPSULE ORAL Rx AB EQ 40MG BASE CAPSULE ORAL Rx AB EQ 60MG BASE CAPSULE ORAL Rx AB EQ 80MG BASE CAPSULE ORAL Rx AB EQ 100MG BASE CAPSULE ORAL Rx AB
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
24 yr 1 mo ago
Most recent approval
2 mo ago
Approvals span 2002–2026 across 11 FDA applications.
Brand (NDA) 218%
Generic (ANDA) 982%
Atomoxetine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
