Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209253
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMPHETAMINE | AMPHETAMINE | EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
AMPHETAMINE | AMPHETAMINE | EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
AMPHETAMINE | AMPHETAMINE | EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
AMPHETAMINE | AMPHETAMINE | EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
AMPHETAMINE | AMPHETAMINE | EQ 15.7MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
AMPHETAMINE | AMPHETAMINE | EQ 18.8MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
06/22/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209253Orig1s000ltr.pdf |