Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021282
Company: RB HLTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MUCINEX GUAIFENESIN 600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter None Yes No
MUCINEX GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/12/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21282lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21282ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-282_Mucinex.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/19/2021 SUPPL-54 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021282s054,021620s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021282Orig1s054; 021620Orig1s043ltr.pdf
04/02/2020 SUPPL-51 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021282Orig1s051ltr.pdf
10/27/2017 SUPPL-49 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021282s049lbl.pdf
07/03/2017 SUPPL-48 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021282Orig1s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021282Orig1s48ltr.pdf
10/19/2015 SUPPL-46 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021282Orig1s046ltr.pdf
03/09/2015 SUPPL-45 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021282Orig1s045ltr.pdf
09/10/2014 SUPPL-44 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021282Orig1s044ltr.pdf
05/22/2014 SUPPL-43 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021282s043, 021585s030ltr.pdf
05/12/2011 SUPPL-37 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-35 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021282Orig1s035,021620Orig1s029ltr.pdf
11/24/2009 SUPPL-31 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021282Orig1s031ltr.pdf
04/03/2009 SUPPL-29 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021282s029ltr.pdf
08/20/2008 SUPPL-25 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021282s025ltr.pdf
09/06/2007 SUPPL-21 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
11/14/2006 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021282s016ltr.pdf
08/23/2006 SUPPL-11 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021282s011ltr.pdf
12/18/2002 SUPPL-1 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21282scf001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/19/2021 SUPPL-54 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021282s054,021620s043lbl.pdf
10/27/2017 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021282s049lbl.pdf
07/03/2017 SUPPL-48 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021282Orig1s048lbl.pdf
09/06/2007 SUPPL-21 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021282s021,021585s012,021620s011lbl.pdf
07/12/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21282lbl.pdf

MUCINEX

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; 600MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 207342 AMNEAL PHARMS
GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 210453 AUROBINDO PHARMA LTD
GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 213420 GRANULES
GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 209215 GUARDIAN DRUG
GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 078912 PERRIGO R AND D
MUCINEX GUAIFENESIN 600MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 021282 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; 1.2GM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 091009 ACTAVIS LABS FL
GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 207342 AMNEAL PHARMS
GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 210453 AUROBINDO PHARMA LTD
GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 213420 GRANULES
GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 209215 GUARDIAN DRUG
GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 078912 PERRIGO R AND D
MUCINEX GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 021282 RB HLTH

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