You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 4, 2024

Details for New Drug Application (NDA): 207219


✉ Email this page to a colleague

« Back to Dashboard


NDA 207219 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-eight 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-nine suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 207219
Tradename:DULOXETINE HYDROCHLORIDE
Applicant:Yaopharma Co Ltd
Ingredient:duloxetine hydrochloride
Patents:0
Pharmacology for NDA: 207219
Suppliers and Packaging for NDA: 207219
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 207219 ANDA Yaopharma Co., Ltd. 50771-201 50771-201-01 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-201-01)
DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 207219 ANDA Yaopharma Co., Ltd. 50771-202 50771-202-01 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-202-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Aug 16, 2019TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 30MG BASE
Approval Date:Aug 16, 2019TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 60MG BASE
Approval Date:Aug 16, 2019TE:RLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.