Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021585
Company: RB HLTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MUCINEX D GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600MG;60MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter None Yes No
MUCINEX D GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 1.2GM;120MG 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
06/22/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21585_mucinex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21585ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021585s000_MucinexTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/13/2017 SUPPL-33 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
05/22/2014 SUPPL-30 Manufacturing (CMC)-Facility Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021282s043, 021585s030ltr.pdf
08/02/2013 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

05/12/2011 SUPPL-26 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021282Orig1s037,021585Orig1s026,021620Orig1s031ltr.pdf
12/20/2010 SUPPL-25 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021585s025ltr.pdf
09/06/2007 SUPPL-12 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
01/24/2005 SUPPL-2 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21585s002,21620s001ltr.pdf
02/23/2005 SUPPL-1 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21585s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/13/2017 SUPPL-33 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021620Orig1s038,021585Orig1s033lbl.pdf
09/06/2007 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021282s021,021585s012,021620s011lbl.pdf
06/22/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21585_mucinex_lbl.pdf

MUCINEX D

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;60MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600MG;60MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 091071 ACTAVIS LABS FL
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600MG;60MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 213203 AUROBINDO PHARMA LTD
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600MG;60MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 208369 DR REDDYS LABS LTD
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600MG;60MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 212542 SUN PHARM INDS INC
MUCINEX D GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600MG;60MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 021585 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;120MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 1.2GM;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 091071 ACTAVIS LABS FL
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 1.2GM;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 213203 AUROBINDO PHARMA LTD
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 1.2GM;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 208369 DR REDDYS LABS LTD
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 1.2GM;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 212542 SUN PHARM INDS INC
MUCINEX D GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 1.2GM;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 021585 RB HLTH

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