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 |
| 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 |