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
CYCLAPEN-W از شرکت WYETH AYERST
New Drug Application (NDA): 050508
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLAPEN-W | CYCLACILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Discontinued |
None |
No | No |
| CYCLAPEN-W | CYCLACILLIN | 250MG/5ML | FOR SUSPENSION;ORAL | Discontinued |
None |
No | No |
| CYCLAPEN-W | CYCLACILLIN | 500MG/5ML | FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 09/14/1979 | 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 |
|---|---|---|---|---|---|
| 08/17/1982 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/04/1982 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/08/1982 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/27/1982 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/08/1982 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/04/1982 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/1982 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/28/1980 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/25/1980 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/22/1980 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/30/1979 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/19/1979 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/12/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/24/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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