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FDA ANDA · ANDA077213

CITALOPRAM HYDROBROMIDE

Sponsor: HERITAGE PHARMA

APPLICATION
ANDA077213
TYPE
ANDA
ORIGINAL APPROVAL
2006-03-31
LATEST ACTION
2024-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CITALOPRAM HYDROBROMIDEDiscontinued
CITALOPRAM HYDROBROMIDE EQ 40MG BASE · TABLET · ORAL
CITALOPRAM HYDROBROMIDEDiscontinued
CITALOPRAM HYDROBROMIDE EQ 10MG BASE · TABLET · ORAL
CITALOPRAM HYDROBROMIDEDiscontinued
CITALOPRAM HYDROBROMIDE EQ 20MG BASE · TABLET · ORAL

Approval history

2024-07-29Labeling · Supplement 5 · standardAP
2023-08-08Labeling · Supplement 4 · standardAP
2023-08-08Labeling · Supplement 3 · standardAP
2006-03-31OriginalOther Important Information from FDAAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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