APPLICATION
ANDA211767
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-08
LATEST ACTION
2023-10-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CLOMIPRAMINE HYDROCHLORIDEPrescription
CLOMIPRAMINE HYDROCHLORIDE 50MG · CAPSULE · ORAL
CLOMIPRAMINE HYDROCHLORIDEPrescription
CLOMIPRAMINE HYDROCHLORIDE 75MG · CAPSULE · ORAL
CLOMIPRAMINE HYDROCHLORIDEPrescription
CLOMIPRAMINE HYDROCHLORIDE 25MG · CAPSULE · ORAL
Approval history
2023-10-13Manufacturing (CMC) · Supplement 15 · unknownAP
2023-09-21Labeling · Supplement 11 · standardAP
2023-09-21Labeling · Supplement 18 · standardAP
2023-09-21Labeling · Supplement 3 · standardAP
2019-04-08UNKNOWN · Original · standardAP
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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