Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087943
Company: AUXILIUM PHARMS LLC
Company: AUXILIUM PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THEO-24 | THEOPHYLLINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| THEO-24 | THEOPHYLLINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
| THEO-24 | THEOPHYLLINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
| THEO-24 | THEOPHYLLINE | 400MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/22/1983 | 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 |
|---|---|---|---|---|---|
| 03/25/2005 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 12/20/2001 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 10/20/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 02/10/1995 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/25/1989 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/21/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/28/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |