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 APOTEX INC
Abbreviated New Drug Application (ANDA): 078949
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUDESONIDE | BUDESONIDE | 0.032MG/INH | SPRAY, METERED;NASAL | Prescription |
None |
No | No |
| BUDESONIDE | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter |
None |
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 |
|---|---|---|---|---|---|---|---|
| 05/12/2014 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/29/2019 | SUPPL-10 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2015 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
BUDESONIDE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPRAY, METERED;NASAL; 0.032MG/SPRAY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| BUDESONIDE | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | No | 078949 | APOTEX INC |
| RHINOCORT ALLERGY | BUDESONIDE | 0.032MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | Yes | 020746 | J AND J CONSUMER INC |
نظرات کاربران