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
COMPRO از شرکت PADAGIS US
Abbreviated New Drug Application (ANDA): 040246
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
COMPRO | PROCHLORPERAZINE | 25MG | SUPPOSITORY;RECTAL | 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 |
---|---|---|---|---|---|---|---|
06/28/2000 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40246ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/23/2017 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
10/25/2011 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
12/03/2010 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
07/07/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
03/03/2009 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
05/15/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
02/09/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
COMPRO
SUPPOSITORY;RECTAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
COMPRO | PROCHLORPERAZINE | 25MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040246 | PADAGIS US |
PROCHLORPERAZINE | PROCHLORPERAZINE | 25MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040058 | COSETTE |
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