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Generated: November 14, 2018

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Details for New Drug Application (NDA): 020822

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NDA 020822 describes CELEXA, which is a drug marketed by Forest Labs and Allergan Sales Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the CELEXA profile page.

The generic ingredient in CELEXA is citalopram hydrobromide. There are fifty-six drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the citalopram hydrobromide profile page.
Summary for 020822
Tradename:CELEXA
Applicant:Allergan Sales Llc
Ingredient:citalopram hydrobromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020822
Mechanism of ActionSerotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for 020822
Suppliers and Packaging for NDA: 020822
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CELEXA citalopram hydrobromide TABLET;ORAL 020822 NDA Allergan, Inc. 0456-4010 0456-4010-01 100 TABLET, FILM COATED in 1 BOTTLE (0456-4010-01)
CELEXA citalopram hydrobromide TABLET;ORAL 020822 NDA Allergan, Inc. 0456-4020 0456-4020-01 100 TABLET, FILM COATED in 1 BOTTLE (0456-4020-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Apr 27, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jul 17, 1998TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Jul 17, 1998TE:ABRLD:Yes

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