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
ACETASOL از شرکت ACTAVIS MID ATLANTIC
Abbreviated New Drug Application (ANDA): 087146
Company: ACTAVIS MID ATLANTIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETASOL | ACETIC ACID, GLACIAL | 2% | SOLUTION/DROPS;OTIC | 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 |
|---|---|---|---|---|---|---|---|
| 08/12/1981 | 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 |
|---|---|---|---|---|---|
| 12/29/2000 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/07/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/17/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/15/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
منبع : www.accessdata.fda.gov
نظرات کاربران