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
AMITRIPTYLINE HYDROCHLORIDE از شرکت MUTUAL PHARM
Abbreviated New Drug Application (ANDA): 085742
Company: MUTUAL PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/13/1977 | 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 |
|---|---|---|---|---|---|
| 12/01/1998 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1995 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1993 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1992 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 12/30/1991 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 02/28/1990 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 02/28/1990 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1987 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1987 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1987 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1987 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1986 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1985 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1985 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1989 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1982 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1982 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
نظرات کاربران