APPLICATION
ANDA205619
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-17
LATEST ACTION
2024-10-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 10MG BASE · TABLET · ORAL
ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 20MG BASE · TABLET · ORAL
ESCITALOPRAM OXALATEPrescription
ESCITALOPRAM OXALATE EQ 5MG BASE · TABLET · ORAL
Approval history
2024-10-02Labeling · Supplement 8 · standardAP
2024-10-02Labeling · Supplement 7 · standardAP
2023-02-16Labeling · Supplement 6 · standardAP
2023-02-16Labeling · Supplement 4 · standardAP
2023-02-16Labeling · Supplement 2 · standardAP
2023-02-16Labeling · Supplement 5 · standardAP
2017-05-17UNKNOWN · 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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