Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078940
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 18MG | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 25MG | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 40MG | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 60MG | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 80MG | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | None (Tentative Approval) | 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 |
---|---|---|---|---|---|---|---|
05/11/2012 | ORIG-1 | Tentative Approval |
Label is not available on this site. |