Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207219
Company: YAOPHARMA CO LTD
Company: YAOPHARMA CO LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | No | No |
DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | No | No |
DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;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 |
---|---|---|---|---|---|---|---|
08/16/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |