Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

US Department of Justice
Mallinckrodt
Harvard Business School
Queensland Health
Fuji
Chubb
Cantor Fitzgerald
Citi
UBS
Boehringer Ingelheim

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077654

« Back to Dashboard

NDA 077654 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-nine 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. Seventy suppliers are listed for this compound. Additional details are available on the citalopram hydrobromide profile page.
Summary for 077654
Tradename:CITALOPRAM HYDROBROMIDE
Applicant:Glenmark Generics
Ingredient:citalopram hydrobromide
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 68462-113-05 500 TABLET, FILM COATED in 1 BOTTLE (68462-113-05)
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)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Accenture
Moodys
Deloitte
Citi
Fuji
Argus Health
Johnson and Johnson
Baxter

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 verifification 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.

botpot