U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022424
Company: CHARTWELL RX

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLOWTUSS GUAIFENESIN; HYDROCODONE BITARTRATE 200MG/5ML;2.5MG/5ML SOLUTION;ORAL Discontinued None No No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/22/2025 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022424s004lbl.pdf
12/22/2025 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022424s004lbl.pdf
12/15/2023 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022424s003lbl.pdf
06/28/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022424s002lbl.pdf
01/13/2017 SUPPL-1 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022424s001lbl.pdf
01/13/2017 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022424s001lbl.pdf
05/14/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022424Orig1s00lbl.pdf
Back to Top