Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020929
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PULMICORT RESPULES | BUDESONIDE | 0.25MG/2ML | SUSPENSION;INHALATION | Prescription | AN | Yes | No |
| PULMICORT RESPULES | BUDESONIDE | 0.5MG/2ML | SUSPENSION;INHALATION | Prescription | AN | Yes | No |
| PULMICORT RESPULES | BUDESONIDE | 1MG/2ML | SUSPENSION;INHALATION | Prescription | AN | 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 |
|---|---|---|---|---|---|---|---|
| 08/08/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20929lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20929ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-929_Pulmicort.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/06/2019 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020929s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020929Orig1s052ltr.pdf | |
| 08/18/2015 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/2013 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/2013 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/2010 | SUPPL-44 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020929s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020929s044ltr.pdf | |
| 10/05/2009 | SUPPL-43 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020929s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020929s043ltr.pdf | |
| 06/15/2007 | SUPPL-34 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/18/2007 | SUPPL-32 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020929s032ltr.pdf |
| 11/20/2006 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 06/30/2005 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020929s022ltr.pdf |
| 09/26/2003 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20929slr015_pulmicort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr018,20746slr011,20929slr015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020929_S015_PULMICORT_TURBOHALER_AP.pdf | |
| 02/26/2003 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020929s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20929se8-013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020929_S013_PULMICORT_RESPULES_AP.pdf | |
| 01/10/2003 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20929slr012ltr.pdf |
| 07/25/2002 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/2006 | SUPPL-2 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020929s002ltr.pdf |
| 02/09/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/06/2019 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020929s052lbl.pdf | |
| 07/02/2010 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020929s044lbl.pdf | |
| 10/05/2009 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020929s043lbl.pdf | |
| 09/26/2003 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20929slr015_pulmicort_lbl.pdf | |
| 02/26/2003 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020929s013lbl.pdf | |
| 08/08/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20929lbl.pdf |
PULMICORT RESPULES
SUSPENSION;INHALATION; 0.25MG/2ML
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUDESONIDE | BUDESONIDE | 0.25MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 205710 | CIPLA |
| BUDESONIDE | BUDESONIDE | 0.25MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 078404 | IMPAX LABS INC |
| BUDESONIDE | BUDESONIDE | 0.25MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 078202 | NEPHRON |
| BUDESONIDE | BUDESONIDE | 0.25MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 201966 | SANDOZ |
| BUDESONIDE | BUDESONIDE | 0.25MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 211922 | SUN PHARM |
| BUDESONIDE | BUDESONIDE | 0.25MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 077519 | TEVA PHARMS |
| PULMICORT RESPULES | BUDESONIDE | 0.25MG/2ML | SUSPENSION;INHALATION | Prescription | Yes | AN | 020929 | ASTRAZENECA |
SUSPENSION;INHALATION; 0.5MG/2ML
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUDESONIDE | BUDESONIDE | 0.5MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 205710 | CIPLA |
| BUDESONIDE | BUDESONIDE | 0.5MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 078404 | IMPAX LABS INC |
| BUDESONIDE | BUDESONIDE | 0.5MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 210897 | LUPIN |
| BUDESONIDE | BUDESONIDE | 0.5MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 078202 | NEPHRON |
| BUDESONIDE | BUDESONIDE | 0.5MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 201966 | SANDOZ |
| BUDESONIDE | BUDESONIDE | 0.5MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 211922 | SUN PHARM |
| BUDESONIDE | BUDESONIDE | 0.5MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 077519 | TEVA PHARMS |
| PULMICORT RESPULES | BUDESONIDE | 0.5MG/2ML | SUSPENSION;INHALATION | Prescription | Yes | AN | 020929 | ASTRAZENECA |
SUSPENSION;INHALATION; 1MG/2ML
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUDESONIDE | BUDESONIDE | 1MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 205710 | CIPLA |
| BUDESONIDE | BUDESONIDE | 1MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 201966 | SANDOZ |
| BUDESONIDE | BUDESONIDE | 1MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 211922 | SUN PHARM |
| BUDESONIDE | BUDESONIDE | 1MG/2ML | SUSPENSION;INHALATION | Prescription | No | AN | 204548 | TEVA PHARMS USA |
| PULMICORT RESPULES | BUDESONIDE | 1MG/2ML | SUSPENSION;INHALATION | Prescription | Yes | AN | 020929 | ASTRAZENECA |