Details for New Drug Application (NDA): 220320
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NDA 220320 describes ATONCY, which is a drug marketed by Map77 and is included in one NDA. It is available from two suppliers. Additional details are available on the ATONCY profile page.
The generic ingredient in ATONCY 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 ATONCY 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 220320
| Tradename: | ATONCY |
| Applicant: | Map77 |
| Ingredient: | atomoxetine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 220320
| Mechanism of Action | Norepinephrine Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 220320
Suppliers and Packaging for NDA: 220320
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATONCY | atomoxetine hydrochloride | SOLUTION;ORAL | 220320 | NDA | Validus Pharmaceuticals LLC | 30698-456 | 30698-456-02 | 1 BOTTLE, GLASS in 1 CARTON (30698-456-02) / 100 mL in 1 BOTTLE, GLASS |
| ATONCY | atomoxetine hydrochloride | SOLUTION;ORAL | 220320 | NDA AUTHORIZED GENERIC | Advagen Pharma Ltd. | 72888-456 | 72888-456-01 | 1 BOTTLE, GLASS in 1 CARTON (72888-456-01) / 100 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 4MG BASE/ML | ||||
| Approval Date: | Mar 20, 2026 | TE: | RLD: | Yes | |||||
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