Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021282
Company: RB HLTH
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 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021282Orig1s031lbl.pdf 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 |
| 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 |
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 |
| GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 215932 | DR REDDYS |
| 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 | 217780 | MARKSANS PHARMA |
| GUAIFENESIN | GUAIFENESIN | 600MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 209254 | OHM LABS INC |
| 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 |
| GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 215932 | DR REDDYS |
| 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 | 217780 | MARKSANS PHARMA |
| GUAIFENESIN | GUAIFENESIN | 1.2GM | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 209254 | OHM LABS INC |
| 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 |