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
ALCOHOL 10% AND DEXTROSE 5% از شرکت B BRAUN
New Drug Application (NDA): 004589
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALCOHOL 10% AND DEXTROSE 5% | ALCOHOL; DEXTROSE | 10ML/100ML;5GM/100ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
ALCOHOL 5% AND DEXTROSE 5% | ALCOHOL; DEXTROSE | 5ML/100ML;5GM/100ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
01/17/1946 | 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 |
---|---|---|---|---|---|
10/11/1985 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
06/14/1985 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/09/1984 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/04/1982 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
01/19/1982 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
10/01/1980 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/16/1978 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/28/1977 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
06/28/1977 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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