Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086742
Company: WARNER CHILCOTT LLC
Company: WARNER CHILCOTT LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHOLEDYL SA | OXTRIPHYLLINE | 600MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/05/1981 | 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 |
|---|---|---|---|---|---|
| 06/08/1999 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 06/08/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/08/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/19/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 08/12/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1990 | SUPPL-10 | Bioequivalence |
Label is not available on this site. |
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| 08/21/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1988 | SUPPL-7 | Bioequivalence |
Label is not available on this site. |
||
| 01/10/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/10/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |