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Generated: August 22, 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 Apotex Inc, Jubilant Generics, Aurobindo Pharma Ltd, Teva Pharms, Torrent Pharms, Silarx, Aurobindo, Pliva, Sun Pharm Inds Inc, Actavis Elizabeth, Invagen Pharms, Watson Labs, Sandoz, Epic Pharma Llc, Mylan Pharms Inc, Dr Reddys Labs Ltd, Mylan, Natco Pharma Ltd, Roxane, West-ward Pharms Int, Cipla Ltd, Epic Pharma, Torpharm, G And W Labs Inc, Hetero Labs Ltd Iii, Sun Pharm Inds, Glenmark Generics, Biovail Labs Intl, Taro, and Amneal Pharms Ny, and is included in thirty-three NDAs. It is available from sixty-seven suppliers. Additional details are available on the CITALOPRAM HYDROBROMIDE profile page.

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

Summary for NDA: 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

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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Fuji
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