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FDA NDA · NDA210632

LEVOTHYROXINE SODIUM

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA210632
TYPE
NDA
ORIGINAL APPROVAL
2019-04-11
LATEST ACTION
2019-04-11
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

LEVOTHYROXINE SODIUM · ReferencePrescription
LEVOTHYROXINE SODIUM 200MCG/5ML (40MCG/ML) · SOLUTION · INTRAVENOUS
LEVOTHYROXINE SODIUM · ReferencePrescription
LEVOTHYROXINE SODIUM 500MCG/5ML (100MCG/ML) · SOLUTION · INTRAVENOUS
LEVOTHYROXINE SODIUM · ReferencePrescription
LEVOTHYROXINE SODIUM 100MCG/5ML (20MCG/ML) · SOLUTION · INTRAVENOUS

Approval history

2019-04-11Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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