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Generated: November 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077654

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NDA 077654 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-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 077654

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

Pharmacology for NDA: 077654

Mechanism of ActionSerotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 077654

Suppliers and Packaging for NDA: 077654

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CITALOPRAM HYDROBROMIDE
citalopram hydrobromide
TABLET;ORAL 077654 ANDA Glenmark Generics Inc., USA 68462-113 68462-113-01 100 TABLET, FILM COATED in 1 BOTTLE (68462-113-01)
CITALOPRAM HYDROBROMIDE
citalopram hydrobromide
TABLET;ORAL 077654 ANDA Glenmark Generics Inc., USA 68462-113 68462-113-05 500 TABLET, FILM COATED in 1 BOTTLE (68462-113-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Feb 27, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Feb 27, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Feb 27, 2009TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Queensland Health
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