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 WEST-WARD PHARMS INT
Abbreviated New Drug Application (ANDA): 083329
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 07/25/1974 | 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-47 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/04/2020 | SUPPL-46 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2010 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/29/2009 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 11/25/2008 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 11/25/2002 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 09/18/2000 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/06/1999 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/06/1999 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/1999 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/1999 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/19/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1993 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 02/27/1992 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1989 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 02/15/1989 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1989 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
CHLORPROMAZINE HYDROCHLORIDE
INJECTABLE;INJECTION; 25MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211816 | AUROBINDO PHARMA LTD |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 083329 | WEST-WARD PHARMS INT |
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