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 از شرکت WOCKHARDT BIO AG
Abbreviated New Drug Application (ANDA): 040166
Company: WOCKHARDT BIO AG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETIC ACID | ACETIC ACID, GLACIAL | 2% | SOLUTION/DROPS;OTIC | Prescription |
AT |
No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/26/1996 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/040166_acetic-acid_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/05/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |
ACETIC ACID
SOLUTION/DROPS;OTIC; 2%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETIC ACID | ACETIC ACID, GLACIAL | 2% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 207280 | RISING |
| ACETIC ACID | ACETIC ACID, GLACIAL | 2% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 040607 | SAPTALIS PHARMS |
| ACETIC ACID | ACETIC ACID, GLACIAL | 2% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 088638 | TARO |
| ACETIC ACID | ACETIC ACID, GLACIAL | 2% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 040166 | WOCKHARDT BIO AG |
| VOSOL | ACETIC ACID, GLACIAL | 2% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 012179 | AKORN |
منبع : www.accessdata.fda.gov
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