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
ACETYLCYSTEINE از شرکت AM REGENT
Abbreviated New Drug Application (ANDA): 072489
Company: AM REGENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETYLCYSTEINE | ACETYLCYSTEINE | 10% | SOLUTION;INHALATION, ORAL | Prescription |
AN |
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 |
|---|---|---|---|---|---|---|---|
| 07/28/1995 | 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 |
|---|---|---|---|---|---|
| 04/12/2001 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 07/30/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/04/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |
ACETYLCYSTEINE
SOLUTION;INHALATION, ORAL; 10%
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETYLCYSTEINE | ACETYLCYSTEINE | 10% | SOLUTION;INHALATION, ORAL | Prescription | No | AN | 204674 | ALVOGEN |
| ACETYLCYSTEINE | ACETYLCYSTEINE | 10% | SOLUTION;INHALATION, ORAL | Prescription | No | AN | 072489 | AM REGENT |
| ACETYLCYSTEINE | ACETYLCYSTEINE | 10% | SOLUTION;INHALATION, ORAL | Prescription | No | AN | 073664 | HOSPIRA |
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