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 ANI PHARMS
Abbreviated New Drug Application (ANDA): 085031
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Discontinued |
None |
No | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued |
None |
No | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Discontinued |
None |
No | No |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/16/1976 | 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 |
|---|---|---|---|---|---|
| 04/25/2016 | SUPPL-287 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/17/2014 | SUPPL-286 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/18/1997 | SUPPL-285 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1995 | SUPPL-284 | Labeling |
Label is not available on this site. |
||
| 02/15/1995 | SUPPL-283 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-282 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1994 | SUPPL-281 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/1994 | SUPPL-280 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1994 | SUPPL-279 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1994 | SUPPL-278 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1993 | SUPPL-277 | Labeling |
Label is not available on this site. |
||
| 06/12/1992 | SUPPL-276 | Labeling |
Label is not available on this site. |
||
| 12/31/1991 | SUPPL-273 | Labeling |
Label is not available on this site. |
||
| 06/10/1992 | SUPPL-272 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1989 | SUPPL-271 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1988 | SUPPL-269 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1988 | SUPPL-268 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1987 | SUPPL-266 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1987 | SUPPL-265 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1987 | SUPPL-263 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1986 | SUPPL-262 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1986 | SUPPL-261 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1986 | SUPPL-260 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1986 | SUPPL-259 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1985 | SUPPL-257 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1985 | SUPPL-256 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1985 | SUPPL-255 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/1985 | SUPPL-254 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1984 | SUPPL-252 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1985 | SUPPL-251 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1984 | SUPPL-250 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1984 | SUPPL-249 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1983 | SUPPL-248 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/1982 | SUPPL-244 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1983 | SUPPL-239 | Manufacturing (CMC) |
Label is not available on this site. |
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