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FDA NDA · NDA206679

FLOLIPID

Sponsor: SALERNO PHARMS

APPLICATION
NDA206679
TYPE
NDA
ORIGINAL APPROVAL
2016-04-21
LATEST ACTION
2020-09-25
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

FLOLIPID · ReferencePrescription
SIMVASTATIN 40MG/5ML · SUSPENSION · ORAL
FLOLIPID · ReferencePrescription
SIMVASTATIN 20MG/5ML · SUSPENSION · ORAL

Approval history

2020-09-25Labeling · Supplement 3 · 901 required — Letter ↗AP
2017-10-04Labeling · Supplement 2 · standard — Label ↗AP
2016-04-21Type 3 - New Dosage Form · Original · standard — Review ↗AP
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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