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
AMBENYL از شرکت FOREST LABS
New Drug Application (NDA): 009319
Company: FOREST LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMBENYL | BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE | 12.5MG/5ML;10MG/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 04/28/1954 | ORIG-1 | Approval |
Type 4 – New Combination |
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 |
|---|---|---|---|---|---|
| 04/14/1993 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1989 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/1993 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 08/26/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1986 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/10/1984 | SUPPL-18 | Efficacy |
Label is not available on this site. |
||
| 01/10/1984 | SUPPL-17 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
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