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
CHLORPROMAZINE HYDROCHLORIDE از شرکت UPSHER SMITH LABS
Abbreviated New Drug Application (ANDA): 083386
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 07/09/1974 | 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 |
|---|---|---|---|---|---|
| 02/05/2020 | SUPPL-98 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2017 | SUPPL-95 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2016 | SUPPL-94 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/13/2011 | SUPPL-90 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2010 | SUPPL-87 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2009 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 11/19/2008 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 11/25/2002 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
| 03/22/1999 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 03/22/1999 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1996 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1992 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 12/31/1991 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 11/29/1990 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 04/14/1989 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1988 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1988 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 03/08/1988 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 04/14/1988 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1987 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1987 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1987 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1986 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1986 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1986 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1984 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1984 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1984 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
CHLORPROMAZINE HYDROCHLORIDE
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 209755 | AMNEAL PHARMS CO |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212144 | GLENMARK PHARMS LTD |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212996 | LANNETT CO INC |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 214256 | SUN PHARM |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 083386 | UPSHER SMITH LABS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213368 | ZYDUS |
نظرات کاربران