Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201466
Company: BRECKENRIDGE
Company: BRECKENRIDGE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Discontinued | None | No | No |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG/5ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
11/12/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |