Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021585
Company: RB HLTH
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.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/08/2024 | SUPPL-38 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021585Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021585Orig1s038ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 07/08/2024 | SUPPL-38 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021585Orig1s038lbl.pdf | |
| 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 |
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 214407 | L PERRIGO CO |
| 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 |
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 214407 | L PERRIGO CO |
| 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 |