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FDA ANDA · ANDA207442

DEXAMETHASONE SODIUM PHOSPHATE

Sponsor: SOMERSET THERAPS LLC

APPLICATION
ANDA207442
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-19
LATEST ACTION
2024-06-05
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEPrescription
DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML · INJECTABLE · INJECTION

Approval history

2024-06-05Labeling · Supplement 16 · standardAP
2021-05-12Labeling · Supplement 4 · standardAP
2018-04-19UNKNOWN · Original · standardAP
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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