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FDA ANDA · ANDA077812

CITALOPRAM HYDROBROMIDE

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA077812
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-28
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 22 · standardAP
2021-09-20Labeling · Supplement 17 · standardAP
2021-09-13Labeling · Supplement 14 · standardAP
2017-01-04Labeling · Supplement 12 · standardAP
2014-07-17Labeling · Supplement 11 · standardAP
2014-07-15Labeling · Supplement 10 · standardAP
2012-05-29Labeling · Supplement 7AP
2012-05-29Labeling · Supplement 8 · standardAP
2009-02-25Labeling · Supplement 5AP
2009-01-13Labeling · Supplement 4AP
2008-07-02Labeling · Supplement 3AP
2007-10-25Labeling · Supplement 2AP
2007-07-02Labeling · Supplement 1AP
2006-08-28Original — 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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