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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
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
11/24/2009 SUPPL-31 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021282Orig1s031lbl.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
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