← FDA DRUG APPROVALS

FDA NDA · NDA022424

FLOWTUSS

Sponsor: CHARTWELL RX

APPLICATION
NDA022424
TYPE
NDA
ORIGINAL APPROVAL
2015-05-14
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

FLOWTUSSDiscontinued
GUAIFENESIN 200MG/5ML, HYDROCODONE BITARTRATE 2.5MG/5ML · SOLUTION · ORAL

Approval history

2025-12-22Labeling · Supplement 4 · standard — Label ↗AP
2023-12-15Labeling · Supplement 3 · standard — Label ↗AP
2018-06-28Labeling · Supplement 2 · standard — Label ↗AP
2017-01-13Labeling · Supplement 1 · standard — Label ↗AP
2015-05-14Type 4 - New Combination · 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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