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Atomoxetine hydrochlorideis the generic ingredient in two branded drugs marketed by Apotex, Aurobindo Pharma, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd V, Mylan, Teva Pharms Usa, Zydus Pharms Usa Inc, and Lilly, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.
There are fifteen drug master file entries for atomoxetine hydrochloride. Nineteen suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for atomoxetine hydrochloride
|Drug Master File Entries:||15|
|Finished Product Suppliers / Packagers:||19|
|Raw Ingredient (Bulk) Api Vendors:||90|
|Formulation / Manufacturing:||see details|
|What excipients (inactive ingredients) are in atomoxetine hydrochloride?||atomoxetine hydrochloride excipients list|
|DailyMed Link:||atomoxetine hydrochloride at DailyMed|
Recent Clinical Trials for atomoxetine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Elkana Kohn||Phase 2|
|University of Calgary||Phase 4|
Generic filers with tentative approvals for ATOMOXETINE HYDROCHLORIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for atomoxetine hydrochloride
|Drug Class||Norepinephrine Reuptake Inhibitor |
|Mechanism of Action|| Norepinephrine Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for atomoxetine hydrochloride
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Lilly||STRATTERA||atomoxetine hydrochloride||CAPSULE;ORAL||021411-001||Nov 26, 2002||See Plans and Pricing||See Plans and Pricing|
|Lilly||STRATTERA||atomoxetine hydrochloride||CAPSULE;ORAL||021411-004||Nov 26, 2002||See Plans and Pricing||See Plans and Pricing|
|Lilly||STRATTERA||atomoxetine hydrochloride||CAPSULE;ORAL||021411-005||Nov 26, 2002||See Plans and Pricing||See Plans and Pricing|
|Lilly||STRATTERA||atomoxetine hydrochloride||CAPSULE;ORAL||021411-008||Feb 14, 2005||See Plans and Pricing||See Plans and Pricing|
|Lilly||STRATTERA||atomoxetine hydrochloride||CAPSULE;ORAL||021411-007||Feb 14, 2005||See Plans and Pricing||See Plans and Pricing|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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