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HSA Approval

DEXTENZA Ophthalmic Insert 0.4 mg

SIN17195P

DEXTENZA Ophthalmic Insert 0.4 mg

DEXTENZA Ophthalmic Insert 0.4 mg

March 5, 2025

LABCORP DEVELOPMENT (ASIA) PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantLABCORP DEVELOPMENT (ASIA) PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INSERT, EXTENDED RELEASE

OPHTHALMIC

Medical Information

S01BA01

Manufacturer Information

LABCORP DEVELOPMENT (ASIA) PTE. LTD.

Ocular Therapeutix, Inc.

Isomedix Operations Inc. dba Steris Applied Sterilization Technologies (Contract Sterilization)

Active Ingredients

Dexamethasone (micronized)

0.4 mg

Dexamethasone

Documents

Package Inserts

Dextenza Ophthalmic Insert PI.pdf

Approved: March 5, 2025

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DEXTENZA Ophthalmic Insert 0.4 mg - HSA Approval | MedPath