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): 084114
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 07/09/1974 | 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-123 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2017 | SUPPL-119 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2016 | SUPPL-118 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/13/2011 | SUPPL-114 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2010 | SUPPL-111 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/24/2009 | SUPPL-108 | Labeling |
Label is not available on this site. |
||
| 11/19/2008 | SUPPL-105 | Labeling |
Label is not available on this site. |
||
| 11/25/2002 | SUPPL-90 | Labeling |
Label is not available on this site. |
||
| 03/22/1999 | SUPPL-89 | Labeling |
Label is not available on this site. |
||
| 03/22/1999 | SUPPL-88 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1996 | SUPPL-87 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1992 | SUPPL-86 | Labeling |
Label is not available on this site. |
||
| 12/31/1991 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 11/29/1990 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 04/26/1988 | SUPPL-82 | Labeling |
Label is not available on this site. |
||
| 07/05/1988 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1988 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 04/14/1988 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1987 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1987 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1987 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1986 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1986 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1986 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1986 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1984 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1982 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1982 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
CHLORPROMAZINE HYDROCHLORIDE
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 209755 | AMNEAL PHARMS CO |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 212144 | GLENMARK PHARMS LTD |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 212996 | LANNETT CO INC |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 214256 | SUN PHARM |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 084114 | UPSHER SMITH LABS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 213368 | ZYDUS |
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