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
COMPAZINE از شرکت GLAXOSMITHKLINE
New Drug Application (NDA): 011127
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COMPAZINE | PROCHLORPERAZINE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SUPPOSITORY;RECTAL | Discontinued |
None |
No | No |
| COMPAZINE | PROCHLORPERAZINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SUPPOSITORY;RECTAL | Discontinued |
None |
No | No |
| COMPAZINE | PROCHLORPERAZINE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SUPPOSITORY;RECTAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 01/26/1959 | ORIG-1 | Approval |
Type 2 – New Active Ingredient |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/03/2001 | SUPPL-61 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf |
|
| 05/09/1997 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/11/1994 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/1992 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1979 | SUPPL-28 | Labeling |
Label is not available on this site. |
منبع : www.accessdata.fda.gov
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