Drugs@FDA: FDA-Approved Drugs
Company: SCHERING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THEO-DUR | THEOPHYLLINE | 450MG | 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 |
---|---|---|---|---|---|---|---|
06/25/1986 | 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 |
---|---|---|---|---|---|
01/10/2002 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
08/18/1997 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
08/18/1997 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
07/17/1996 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
11/21/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
11/21/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/22/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/22/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/26/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
08/20/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/20/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/20/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/20/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/20/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/20/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |