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
BILOPAQUE از شرکت GE HEALTHCARE
New Drug Application (NDA): 013731
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BILOPAQUE | TYROPANOATE SODIUM | 750MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 10/24/1969 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/21/1991 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1990 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/22/1988 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 05/20/1987 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/18/1986 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 07/11/1986 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1984 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/11/1984 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/1984 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/30/1982 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 01/25/1980 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1979 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/1982 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/14/1979 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/28/1978 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/30/1978 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1977 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/08/1977 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/11/1976 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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