Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206336
Company: AARXION ANDA HLDING
Company: AARXION ANDA HLDING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BALSALAZIDE DISODIUM | BALSALAZIDE DISODIUM | 1.1GM | TABLET;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 09/08/2015 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206336Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/07/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/25/2023 | SUPPL-1 | Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |