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FDA ANDA · ANDA208369

GUAIFENESIN AND PSEUDOEPHEDRINE HCL

Sponsor: DR REDDYS

APPLICATION
ANDA208369
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-29
LATEST ACTION
2018-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEOver-the-counter
GUAIFENESIN 1.2GM, PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · TABLET, EXTENDED RELEASE · ORAL
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEOver-the-counter
GUAIFENESIN 600MG, PSEUDOEPHEDRINE HYDROCHLORIDE 60MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2018-04-23Labeling · Supplement 1 · standardAP
2017-12-29UNKNOWN · Original · standardAP
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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