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FDA ANDA · ANDA040491

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA040491
TYPE
ANDA
ORIGINAL APPROVAL
2003-04-11
LATEST ACTION
2024-06-05
ROUTE
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 15 · standardAP
2020-08-06Labeling · Supplement 10 · standardAP
2014-07-03Labeling · Supplement 8 · standard — Letter ↗AP
2005-06-09Labeling · Supplement 2AP
2003-04-11OriginalAP
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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