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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078216

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NDA 078216 describes CITALOPRAM HYDROBROMIDE, which is a drug marketed by Mylan Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Silarx, West-ward Pharms Int, Biovail Labs Intl, Actavis Elizabeth, Amneal Pharms Ny, Aurobindo, Cipla Ltd, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, G And W Labs Inc, Glenmark Generics, Invagen Pharms, Jubilant Generics, Mylan, Natco Pharma Ltd, Pliva, Roxane, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Taro, Teva Pharms, Torpharm, Torrent Pharms, and Watson Labs, and is included in thirty-three NDAs. It is available from sixty-eight suppliers. Additional details are available on the CITALOPRAM HYDROBROMIDE profile page.

The generic ingredient in CITALOPRAM HYDROBROMIDE is citalopram hydrobromide. There are fifty-six drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the citalopram hydrobromide profile page.

Summary for 078216

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 078216

Mechanism of ActionSerotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 078216

Suppliers and Packaging for NDA: 078216

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CITALOPRAM HYDROBROMIDE citalopram hydrobromide TABLET;ORAL 078216 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7830 0615-7830-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7830-30) > 5 TABLET in 1 BLISTER PACK
CITALOPRAM HYDROBROMIDE citalopram hydrobromide TABLET;ORAL 078216 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7830 0615-7830-31 31 TABLET in 1 BLISTER PACK (0615-7830-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Mar 27, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Mar 27, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Mar 27, 2007TE:ABRLD:No


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