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FDA ANDA · ANDA077043

CITALOPRAM

Sponsor: HIKMA

APPLICATION
ANDA077043
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-13
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CITALOPRAM HYDROBROMIDEPrescription
CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML · SOLUTION · ORAL

Approval history

2023-08-18Labeling · Supplement 19 · standardAP
2021-09-21Labeling · Supplement 17 · standardAP
2021-09-03Labeling · Supplement 15 · standardAP
2017-01-04Labeling · Supplement 13 · standardAP
2014-07-17Labeling · Supplement 10 · standard — Label ↗AP
2014-06-02Labeling · Supplement 9 · standardAP
2012-05-21Labeling · Supplement 7AP
2012-05-21Labeling · Supplement 8AP
2009-04-06Labeling · Supplement 6AP
2008-07-02Labeling · Supplement 5AP
2007-10-25Labeling · Supplement 3AP
2007-10-25Labeling · Supplement 4AP
2005-05-11Labeling · Supplement 1AP
2004-12-13Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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