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FDA NDA · NDA212516

DRIZALMA SPRINKLE

duloxetine

Sponsor: SUN PHARM

APPLICATION
NDA212516
TYPE
NDA
ORIGINAL APPROVAL
2019-07-19
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription

Products

DRIZALMA SPRINKLE · ReferencePrescription
DULOXETINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DRIZALMA SPRINKLE · ReferencePrescription
DULOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DRIZALMA SPRINKLE · ReferencePrescription
DULOXETINE HYDROCHLORIDE EQ 60MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
DRIZALMA SPRINKLE · ReferencePrescription
DULOXETINE HYDROCHLORIDE EQ 30MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL

Approval history

2023-08-18Labeling · Supplement 5 · standard — Label ↗AP
2021-07-23Efficacy · Supplement 2 · standard — Label ↗AP
2020-06-24Labeling · Supplement 1 · standard — Label ↗AP
2019-07-19Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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