Drugs@FDA: FDA-Approved Drugs
Company: LANNETT CO INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METADATE ER | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET, 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 |
---|---|---|---|---|---|---|---|
06/01/1988 | 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 |
---|---|---|---|---|---|
06/25/2021 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
01/21/2016 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
01/21/2016 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
08/31/2011 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
01/21/2016 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
01/21/2016 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
01/21/2016 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
01/21/2016 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
01/21/2016 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
12/28/2005 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
12/09/2002 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
10/09/2002 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
10/23/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/08/1999 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
10/20/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
02/22/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/08/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/08/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/13/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
07/02/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
09/11/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/25/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/21/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |