Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205457
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUDESONIDE | BUDESONIDE | 9MG | TABLET, EXTENDED 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 |
---|---|---|---|---|---|---|---|
07/03/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205457Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/10/2023 | SUPPL-8 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/10/2023 | SUPPL-5 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
BUDESONIDE
TABLET, EXTENDED RELEASE;ORAL; 9MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUDESONIDE | BUDESONIDE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205457 | ACTAVIS LABS FL INC |
BUDESONIDE | BUDESONIDE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208851 | MYLAN |
UCERIS | BUDESONIDE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 203634 | SALIX |