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
ACETIC ACID 0.25% IN PLASTIC CONTAINER از شرکت B BRAUN
New Drug Application (NDA): 018161
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETIC ACID 0.25% IN PLASTIC CONTAINER | ACETIC ACID, GLACIAL | 250MG/100ML | SOLUTION;IRRIGATION, URETHRAL | Prescription |
AT |
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 |
|---|---|---|---|---|---|---|---|
| 08/06/1979 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
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 |
|---|---|---|---|---|---|
| 05/15/2003 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/28/2002 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/10/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/1990 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/1986 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/05/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1985 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/1982 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/24/1981 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1981 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1981 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1981 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1980 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1980 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1979 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/25/1979 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/24/1979 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
ACETIC ACID 0.25% IN PLASTIC CONTAINER
SOLUTION;IRRIGATION, URETHRAL; 250MG/100ML
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETIC ACID 0.25% IN PLASTIC CONTAINER | ACETIC ACID, GLACIAL | 250MG/100ML | SOLUTION;IRRIGATION, URETHRAL | Prescription | No | AT | 018161 | B BRAUN |
| ACETIC ACID 0.25% IN PLASTIC CONTAINER | ACETIC ACID, GLACIAL | 250MG/100ML | SOLUTION;IRRIGATION, URETHRAL | Prescription | No | AT | 018523 | BAXTER HLTHCARE |
| ACETIC ACID 0.25% IN PLASTIC CONTAINER | ACETIC ACID, GLACIAL | 250MG/100ML | SOLUTION;IRRIGATION, URETHRAL | Prescription | Yes | AT | 017656 | ICU MEDICAL INC |
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