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FDA ANDA · ANDA077038

CITALOPRAM HYDROBROMIDE

Sponsor: DR REDDYS LABS LTD

APPLICATION
ANDA077038
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-28
LATEST ACTION
2024-09-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2024-09-19Labeling · Supplement 17 · standardAP
2024-09-19Labeling · Supplement 18 · standardAP
2024-09-19Labeling · Supplement 16 · standardAP
2024-09-19Labeling · Supplement 19 · standardAP
2015-08-10Labeling · Supplement 11 · standardAP
2015-08-10Labeling · Supplement 14 · standardAP
2012-06-26Labeling · Supplement 10 · standardAP
2012-06-26Labeling · Supplement 9AP
2009-04-06Labeling · Supplement 7AP
2009-01-22Labeling · Supplement 6AP
2008-08-13Labeling · Supplement 4AP
2007-10-19Labeling · Supplement 3AP
2005-04-27Labeling · Supplement 1AP
2004-10-28Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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