Details for New Drug Application (NDA): 090609
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NDA 090609 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 090609
| Tradename: | ATOMOXETINE HYDROCHLORIDE |
| Applicant: | Dr Reddys |
| Ingredient: | atomoxetine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 090609
| Mechanism of Action | Norepinephrine Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 090609
Suppliers and Packaging for NDA: 090609
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 090609 | ANDA | Major Pharmaceuticals | 0904-6908 | 0904-6908-04 | 30 BLISTER PACK in 1 CARTON (0904-6908-04) / 1 CAPSULE in 1 BLISTER PACK |
| ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 090609 | ANDA | Dr. Reddy's Laboratories Limited | 55111-519 | 55111-519-05 | 500 CAPSULE in 1 BOTTLE (55111-519-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Feb 23, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 18MG BASE | ||||
| Approval Date: | Feb 23, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Feb 23, 2018 | TE: | AB | RLD: | No | ||||
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