Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087449
Company: ROXANE
Company: ROXANE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THEOPHYLLINE | THEOPHYLLINE | 80MG/15ML | SOLUTION;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/15/1983 | 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 |
|---|---|---|---|---|---|
| 09/15/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/28/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 03/24/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/10/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |