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FDA ANDA · ANDA213203
GUAIFENESIN AND PSEUDOEPHEDRINE HCL
Sponsor: AUROBINDO PHARMA LTD
APPLICATION
ANDA213203
TYPE
ANDA
ORIGINAL APPROVAL
2020-03-25
LATEST ACTION
2020-03-25
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
2020-03-25UNKNOWN · Original · standardAP
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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