Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208851
Company: MYLAN
Company: MYLAN
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 |
---|---|---|---|---|---|---|---|
09/17/2020 | ORIG-1 | Approval | STANDARD |
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 |