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
BENADRYL از شرکت MCNEIL CONS
New Drug Application (NDA): 006146
Company: MCNEIL CONS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 03/06/1947 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 07/01/1997 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/29/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/20/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/24/1986 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/24/1986 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/10/1984 | SUPPL-6 | Labeling |
Label is not available on this site. |
نظرات کاربران