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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 079021

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NDA 079021 describes ATOMOXETINE HYDROCHLORIDE, which is a drug marketed by Apotex, Aurobindo Pharma, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd V, Strides Pharma, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in eight NDAs. It is available from eighteen suppliers. Additional details are available on the ATOMOXETINE HYDROCHLORIDE profile page.

The generic ingredient in ATOMOXETINE HYDROCHLORIDE is atomoxetine hydrochloride. There are sixteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the atomoxetine hydrochloride profile page.

Summary for 079021

Tradename:	ATOMOXETINE HYDROCHLORIDE
Applicant:	Strides Pharma
Ingredient:	atomoxetine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 079021

Adrenergic Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 10MG BASE
Approval Date:	Feb 18, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 18MG BASE
Approval Date:	Feb 18, 2021	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Feb 18, 2021	TE:	AB	RLD:	No

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