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HSA Approval

DBL DEXAMETHASONE SODIUM PHOSPHATE INJECTION 4 mg/ml

Approval Number

SIN04162P

Drug Name

DBL DEXAMETHASONE SODIUM PHOSPHATE INJECTION 4 mg/ml

Product Name

DBL DEXAMETHASONE SODIUM PHOSPHATE INJECTION 4 mg/ml

Approval Date

April 20, 1990

Registrant

PFIZER PRIVATE LIMITED

Regulatory Information

Registrant

PFIZER PRIVATE LIMITED

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION

Route of Administration

INTRAVENOUS, INTRAMUSCULAR, INTRASYNOVIAL

Medical Information

ATC Code

H02AB02

ATC Item Name

dexamethasone

Manufacturer Information

Pharmaceutical Manufacturer

PFIZER PRIVATE LIMITED

Manufacturers

Wasserburger Arzneimittelwerk GmbH

Active Ingredients

Ingredient Name

DEXAMETHASONE SODIUM PHOSPHATE EQV TO DEXAMETHASONE PHOSPHATE

Strength

4mg/mL

Drug MonographDexamethasone

Documents

Package Inserts

DBL Dexamethasone Sodium Phosphate Injection PI.pdf

Approved: June 21, 2023

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DBL DEXAMETHASONE SODIUM PHOSPHATE INJECTION 4 mg/ml - HSA Approval | MedPath