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FDA ANDA · ANDA213897

CLOMIPRAMINE HYDROCHLORIDE

Sponsor: AJANTA PHARMA LTD

APPLICATION
ANDA213897
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-02
LATEST ACTION
2020-10-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2020-10-02UNKNOWN · Original · standardAP
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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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