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Details for New Drug Application (NDA): 077668

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NDA 077668 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, Corepharma, Mylan Pharms Inc, Dr Reddys Labs Ltd, Mylan, Natco Pharma Ltd, Roxane, Cipla Ltd, Epic Pharma, 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-five 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 NDA: 077668

Mylan Pharms Inc
citalopram hydrobromide
Therapeutic Class:Antidepressants

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Feb 28, 2007TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Feb 28, 2007TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Feb 28, 2007TE:RLD:Yes

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