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Generated: July 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078169

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NDA 078169 describes ESCITALOPRAM OXALATE, which is a drug marketed by Invagen Pharms, Macleods Pharms Ltd, Sti Pharma Llc, Amneal Pharms, Hetero Labs Ltd Iii, Taro, Aurobindo Pharma Ltd, Prinston Inc, Zydus Pharms Usa Inc, Torrent Pharms Ltd, Mylan Pharms Inc, Teva Pharms Usa, Hikma Pharms, Antrim Pharms Llc, Lupin Ltd, Silarx Pharms Inc, Apotex Inc, Jubilant Generics, and Accord Hlthcare, and is included in twenty-three NDAs. It is available from fifty-three suppliers. Additional details are available on the ESCITALOPRAM OXALATE profile page.

The generic ingredient in ESCITALOPRAM OXALATE is escitalopram oxalate. There are twenty-five drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.

Summary for NDA: 078169

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antidepressants
Anxiolytics

Pharmacology for NDA: 078169

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 078169

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESCITALOPRAM OXALATE
escitalopram oxalate
TABLET;ORAL 078169 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7953 0615-7953-39 30 TABLET in 1 BLISTER PACK (0615-7953-39)
ESCITALOPRAM OXALATE
escitalopram oxalate
TABLET;ORAL 078169 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7954 0615-7954-05 15 TABLET in 1 BLISTER PACK (0615-7954-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Sep 11, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Sep 11, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Sep 11, 2012TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Cipla
Medtronic
Cantor Fitzgerald
McKinsey
Julphar
Dow
Novartis
Boehringer Ingelheim
Fish and Richardson

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