Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207602
Company: PERRIGO R AND D
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60MG;1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter None No No
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30MG;600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/05/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, EXTENDED RELEASE;ORAL; 60MG;1.2GM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60MG;1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 091070 ACTAVIS LABS FL
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60MG;1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 209692 AMNEAL PHARMS
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60MG;1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 206941 AUROBINDO PHARMA LTD
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60MG;1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 207602 PERRIGO R AND D
MUCINEX DM DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60MG;1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 021620 RB HLTH

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, EXTENDED RELEASE;ORAL; 30MG;600MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30MG;600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 091070 ACTAVIS LABS FL
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30MG;600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 209692 AMNEAL PHARMS
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30MG;600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 206941 AUROBINDO PHARMA LTD
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30MG;600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 207602 PERRIGO R AND D
MUCINEX DM DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30MG;600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 021620 RB HLTH

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