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FDA ANDA · ANDA074958

CLOMIPRAMINE HYDROCHLORIDE

Sponsor: TEVA

APPLICATION
ANDA074958
TYPE
ANDA
ORIGINAL APPROVAL
1997-08-26
LATEST ACTION
2007-09-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

CLOMIPRAMINE HYDROCHLORIDEDiscontinued
CLOMIPRAMINE HYDROCHLORIDE 75MG · CAPSULE · ORAL
CLOMIPRAMINE HYDROCHLORIDEDiscontinued
CLOMIPRAMINE HYDROCHLORIDE 25MG · CAPSULE · ORAL
CLOMIPRAMINE HYDROCHLORIDEDiscontinued
CLOMIPRAMINE HYDROCHLORIDE 50MG · CAPSULE · ORAL

Approval history

2007-09-14Labeling · Supplement 15AP
2007-06-29Labeling · Supplement 14AP
2005-08-15Labeling · Supplement 13AP
2005-04-14Labeling · Supplement 12AP
2002-10-11Labeling · Supplement 10AP
2002-04-24Labeling · Supplement 9AP
2002-04-24Labeling · Supplement 8AP
1999-12-02Manufacturing (CMC) · Supplement 7AP
1999-12-02Manufacturing (CMC) · Supplement 6AP
1999-02-12Manufacturing (CMC) · Supplement 1AP
1999-02-12Manufacturing (CMC) · Supplement 2AP
1997-08-26OriginalAP
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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