اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CHOLEDYL SA از شرکت WARNER CHILCOTT LLC
Abbreviated New Drug Application (ANDA): 086742
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. |
||
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. |
||
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. |
||
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. |
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