Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079021
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 18MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 02/18/2021 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/15/2023 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |