Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020441
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PULMICORT | BUDESONIDE | 0.16MG/INH | POWDER, METERED;INHALATION | Discontinued | None | No | No |
| PULMICORT | BUDESONIDE | 0.32MG/INH | POWDER, METERED;INHALATION | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/20/2007 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020441s020lbl.pdf | |
| 12/17/2003 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr017_pulmicort_lbl.pdf | |
| 10/24/2003 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr016_pulmicort_lbl.pdf | |
| 09/26/2003 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20929slr015_pulmicort_lbl.pdf | |
| 10/08/1998 | SUPPL-2 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20441s2.lbl.pdf |