DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 090723
NDA 090723 describes DULOXETINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Anchen Pharms, Apotex Inc, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Inventia Hlthcare, Lupin Ltd, Macleods Pharms Ltd, Prinston Inc, Sun Pharma Global, Teva Pharms Usa, Torrent Pharms Ltd, Zydus Hlthcare, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from forty-seven suppliers. Additional details are available on the DULOXETINE HYDROCHLORIDE profile page.
The generic ingredient in DULOXETINE HYDROCHLORIDE is duloxetine hydrochloride. There are forty-one drug master file entries for this compound. Fifty-five 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-one drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 090723
| Tradename: | DULOXETINE HYDROCHLORIDE |
| Applicant: | Dr Reddys Labs Ltd |
| Ingredient: | duloxetine hydrochloride |
| Patents: | 0 |
| Therapeutic Class: | Antidepressants |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090723
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 090723
Suppliers and Packaging for NDA: 090723
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 090723 | ANDA | Medsource Pharmaceuticals | 45865-813 | N | 45865-813-30 |
| DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 090723 | ANDA | Medsource Pharmaceuticals | 45865-813 | N | 45865-813-60 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Dec 11, 2013 | 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: | Dec 11, 2013 | 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: | Dec 11, 2013 | TE: | AB | RLD: | No | ||||
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