Details for New Drug Application (NDA): 078983
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NDA 078983 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 nineteen 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. Twenty-two 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. Twenty-two suppliers are listed for this compound. Additional details are available on the atomoxetine hydrochloride profile page.
Summary for 078983
| Tradename: | ATOMOXETINE HYDROCHLORIDE |
| Applicant: | Apotex |
| Ingredient: | atomoxetine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078983
| Mechanism of Action | Norepinephrine Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 078983
Suppliers and Packaging for NDA: 078983
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 078983 | ANDA | A-S Medication Solutions | 50090-4236 | 50090-4236-0 | 30 CAPSULE in 1 BOTTLE (50090-4236-0) |
| ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 078983 | ANDA | AvPAK | 50268-057 | 50268-057-13 | 30 BLISTER PACK in 1 BOX (50268-057-13) / 1 CAPSULE in 1 BLISTER PACK (50268-057-11) |
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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