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Last Updated: December 30, 2024

Details for New Drug Application (NDA): 090778


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NDA 090778 describes DULOXETINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Breckenridge, Cspc Ouyi, Endo Operations, Hetero Labs Ltd Iii, Inventia, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, 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-nine 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. Fifty suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 090778
Pharmacology for NDA: 090778
Suppliers and Packaging for NDA: 090778
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090778 ANDA Major Pharmaceuticals 0904-7043 0904-7043-04 30 BLISTER PACK in 1 CARTON (0904-7043-04) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 090778 ANDA Major Pharmaceuticals 0904-7043 0904-7043-61 100 BLISTER PACK in 1 CARTON (0904-7043-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Dec 11, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 30MG BASE
Approval Date:Dec 11, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 60MG BASE
Approval Date:Dec 11, 2013TE:ABRLD:No

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