اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BUDESONIDE از شرکت MYLAN
Abbreviated New Drug Application (ANDA): 090410
Company: MYLAN
| 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 |
|
Label is not available on this site. |
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 | 206623 | MAYNE PHARMA |
| BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 090410 | MYLAN |
| BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 207367 | RISING |
| BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 209041 | SCIECURE PHARMA INC |
| 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 |
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