Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206113
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 02/23/2018 | 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 |
|---|---|---|---|---|---|
| 09/08/2023 | SUPPL-6 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206113s006ltr.pdf |
| 05/05/2022 | SUPPL-5 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 10/18/2021 | SUPPL-4 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/06/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |