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FDA ANDA · ANDA204889

VENLAFAXINE HYDROCHLORIDE

Sponsor: MACLEODS PHARMS LTD

APPLICATION
ANDA204889
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-05
LATEST ACTION
2025-04-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

VENLAFAXINE HYDROCHLORIDEPrescription
VENLAFAXINE HYDROCHLORIDE EQ 150MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
VENLAFAXINE HYDROCHLORIDEPrescription
VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
VENLAFAXINE HYDROCHLORIDEPrescription
VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-04-23Labeling · Supplement 17 · standardAP
2025-04-23Labeling · Supplement 28 · standardAP
2025-04-23Labeling · Supplement 16 · standardAP
2025-04-23Labeling · Supplement 20 · standardAP
2023-06-07Labeling · Supplement 18 · standardAP
2018-08-13Labeling · Supplement 1 · standardAP
2017-10-05UNKNOWN · Original · standardLetterAP
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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