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 BAXTER HLTHCARE
New Drug Application (NDA): 018523
Company: BAXTER HLTHCARE
| 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 |
|---|---|---|---|---|---|---|---|
| 02/19/1982 | 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 |
|---|---|---|---|---|---|
| 09/26/2014 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/2011 | SUPPL-20 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/26/1999 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/14/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1990 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-2 | 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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