Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206200
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
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 |
---|---|---|---|---|---|---|---|
07/31/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/29/2021 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient 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 |