Details for New Drug Application (NDA): 079016
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NDA 079016 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.
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 079016
| Tradename: | ATOMOXETINE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | atomoxetine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 079016
| Mechanism of Action | Norepinephrine Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 079016
Suppliers and Packaging for NDA: 079016
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 079016 | ANDA | Burel Pharmaceuticals, LLC | 35573-415 | 35573-415-30 | 30 CAPSULE in 1 BOTTLE (35573-415-30) |
| ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 079016 | ANDA | Burel Pharmaceuticals, LLC | 35573-416 | 35573-416-30 | 30 CAPSULE in 1 BOTTLE (35573-416-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | May 30, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 18MG BASE | ||||
| Approval Date: | May 30, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | May 30, 2017 | TE: | AB | RLD: | No | ||||
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