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): 085744
Company: MUTUAL PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/21/1977 | 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-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1995 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1993 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1992 | SUPPL-70 | Labeling |
Label is not available on this site. |
||
| 12/30/1991 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 02/28/1990 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 02/28/1990 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1988 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1987 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1986 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/27/1985 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1986 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
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