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FDA ANDA · ANDA216082

GUAIFENESIN AND PSEUDOEPHEDRINE HCL

Sponsor: GRANULES

APPLICATION
ANDA216082
TYPE
ANDA
ORIGINAL APPROVAL
2022-08-22
LATEST ACTION
2022-08-22
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEDiscontinued
GUAIFENESIN 1.2GM, PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · TABLET, EXTENDED RELEASE · ORAL
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEDiscontinued
GUAIFENESIN 600MG, PSEUDOEPHEDRINE HYDROCHLORIDE 60MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2022-08-22UNKNOWN · Original · standardAP
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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