Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090410
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 05/16/2011 | ORIG-1 | Approval |
Review (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090410Orig1s000Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090410Orig1s000BioeqR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/29/2021 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/29/2021 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 07/29/2021 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 07/29/2021 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
BUDESONIDE
CAPSULE, DELAYED RELEASE;ORAL; 3MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 206200 | AMNEAL PHARMS |
| BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 090410 | AUROBINDO PHARMA USA |
| BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 206623 | DR REDDYS LABS SA |
| BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 207367 | RISING |
| BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 206134 | ZYDUS PHARMS |
| ENTOCORT EC | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 021324 | PADAGIS US |