Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077519
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUDESONIDE | BUDESONIDE | 0.25MG/2ML | SUSPENSION;INHALATION | Prescription | AN | No | No |
| BUDESONIDE | BUDESONIDE | 0.5MG/2ML | SUSPENSION;INHALATION | Prescription | AN | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/18/2008 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077519s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/31/2021 | SUPPL-14 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 06/03/2015 | SUPPL-13 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/14/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
BUDESONIDE
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 | 216667 | EUGIA PHARMA |
| 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 |