Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021620
Company: RB HLTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MUCINEX DM DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60MG;1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter None Yes Yes
MUCINEX DM DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30MG;600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter None Yes 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
04/29/2004 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21620_mucinex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21620ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021620s000_MucinexTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/03/2019 SUPPL-39 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021620Orig1s039ltr.pdf
07/13/2017 SUPPL-38 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021620Orig1s038,021585Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021620Orig1s038,021585Orig1s033ltr.pdf
04/07/2015 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

09/05/2014 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

05/12/2011 SUPPL-31 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021282Orig1s037,021585Orig1s026,021620Orig1s031ltr.pdf
03/11/2011 SUPPL-29 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021282Orig1s035,021620Orig1s029ltr.pdf
04/03/2009 SUPPL-21 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021620s021ltr.pdf
09/06/2007 SUPPL-11 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021282s021,021585s012,021620s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021282s021, 021585s012, 021620s011_ltr.pdf
01/26/2006 SUPPL-5 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021620s005ltr.pdf
01/24/2005 SUPPL-1 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21585s002,21620s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/13/2017 SUPPL-38 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021620Orig1s038,021585Orig1s033lbl.pdf
09/06/2007 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021282s021,021585s012,021620s011lbl.pdf
04/29/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21620_mucinex_lbl.pdf

MUCINEX DM

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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