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FDA ANDA · ANDA209215

FOSTER AND THRIVE MUCUS RELIEF

guaifenesin

Sponsor: GUARDIAN DRUG

APPLICATION
ANDA209215
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-06
LATEST ACTION
2017-09-06
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

GUAIFENESINOver-the-counter
GUAIFENESIN 1.2GM · TABLET, EXTENDED RELEASE · ORAL
GUAIFENESINOver-the-counter
GUAIFENESIN 600MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2017-09-06UNKNOWN · Original · standardLetterAP
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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