Details for New Drug Application (NDA): 203088
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NDA 203088 describes DULOXETINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Adaptis, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Breckenridge, Cspc Ouyi, Hetero Labs Ltd Iii, Inventia, Lupin Ltd, Macleods Pharms Ltd, Ph Health, Prinston Inc, Qingdao Baheal Pharm, Sun Pharm, Sunshine, Teva Pharms Usa, Torrent, Yaopharma Co Ltd, Zydus Hlthcare, and Zydus Pharms, and is included in twenty-three NDAs. It is available from forty-five suppliers. Additional details are available on the DULOXETINE HYDROCHLORIDE profile page.
The generic ingredient in DULOXETINE HYDROCHLORIDE is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
The generic ingredient in DULOXETINE HYDROCHLORIDE is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 203088
| Tradename: | DULOXETINE HYDROCHLORIDE |
| Applicant: | Breckenridge |
| Ingredient: | duloxetine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 203088
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 203088
Suppliers and Packaging for NDA: 203088
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 203088 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-025 | 43353-025-30 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-30) |
| DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 203088 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-025 | 43353-025-60 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Jun 11, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Jun 11, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 60MG BASE | ||||
| Approval Date: | Jun 11, 2014 | TE: | AB | RLD: | No | ||||
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