Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Accenture
Johnson and Johnson
Cipla
Express Scripts
McKinsey

Generated: August 25, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077534

  Try a free trial


See Plans and Pricing

« Back to Dashboard

NDA 077534 describes CITALOPRAM HYDROBROMIDE, which is a drug marketed by Mylan Pharms Inc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Lannett Co Inc, Pd Partners, West-ward Pharms Int, Biovail Labs Intl, Acp Nimble, Amneal Pharms Ny, Apotex Inc, Aurobindo, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, Fosun Pharma, Glenmark Generics, Heritage Pharma, Invagen Pharms, Jubilant Generics, Mylan, Natco Pharma Ltd, Roxane, Sun Pharm Inds Inc, Sun Pharm Industries, Taro, Torpharm, and Torrent Pharms, 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 077534
Tradename:CITALOPRAM HYDROBROMIDE
Applicant:Invagen Pharms
Ingredient:citalopram hydrobromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077534
Mechanism of ActionSerotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for 077534
Suppliers and Packaging for NDA: 077534
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CITALOPRAM HYDROBROMIDE citalopram hydrobromide TABLET;ORAL 077534 ANDA Camber Pharmaceuticals 31722-206 31722-206-01 100 TABLET in 1 BOTTLE (31722-206-01)
CITALOPRAM HYDROBROMIDE citalopram hydrobromide TABLET;ORAL 077534 ANDA Camber Pharmaceuticals 31722-206 31722-206-05 500 TABLET in 1 BOTTLE (31722-206-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Oct 3, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Oct 3, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Oct 3, 2006TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Army
Teva
Citi
Healthtrust
Mallinckrodt
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.