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FDA ANDA · ANDA204083

DESVENLAFAXINE

Sponsor: HIKMA

APPLICATION
ANDA204083
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-16
LATEST ACTION
2024-09-04
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

DESVENLAFAXINE SUCCINATEPrescription
DESVENLAFAXINE SUCCINATE EQ 25MG BASE · TABLET, EXTENDED RELEASE · ORAL
DESVENLAFAXINE SUCCINATEPrescription
DESVENLAFAXINE SUCCINATE EQ 50MG BASE · TABLET, EXTENDED RELEASE · ORAL
DESVENLAFAXINE SUCCINATEPrescription
DESVENLAFAXINE SUCCINATE EQ 100MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-09-04Labeling · Supplement 10 · standardAP
2024-09-04Labeling · Supplement 6 · standardAP
2024-09-04Labeling · Supplement 7 · standardAP
2019-10-30Labeling · Supplement 4 · standardAP
2017-09-05Labeling · Supplement 2 · standardAP
2017-01-06Labeling · Supplement 1 · standardAP
2016-02-16UNKNOWN · OriginalLetterAP
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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