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Last Updated: August 11, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077629

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NDA 077629 describes CITALOPRAM HYDROBROMIDE, which is a drug marketed by Mylan Pharms Inc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Hikma, Lannett Co Inc, Pharm Assoc, Biovail Labs Intl, Amneal Pharms Ny, Apotex Inc, Aurobindo, Chartwell Molecular, Cosette, 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 forty-four 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. Forty-five suppliers are listed for this compound. Additional details are available on the citalopram hydrobromide profile page.
Summary for 077629
Tradename:CITALOPRAM HYDROBROMIDE
Applicant:Lannett Co Inc
Ingredient:citalopram hydrobromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077629
Mechanism of ActionSerotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for 077629
Suppliers and Packaging for NDA: 077629
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CITALOPRAM HYDROBROMIDE citalopram hydrobromide SOLUTION;ORAL 077629 ANDA Pharmaceutical Associates, Inc. 0121-0848 0121-0848-40 4 TRAY in 1 CASE (0121-0848-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0848-05)
CITALOPRAM HYDROBROMIDE citalopram hydrobromide SOLUTION;ORAL 077629 ANDA Pharmaceutical Associates, Inc. 0121-1696 0121-1696-40 4 TRAY in 1 CASE (0121-1696-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-1696-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 10MG BASE/5ML
Approval Date:Jun 15, 2006TE:AARLD:No

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