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
COL-PROBENECID از شرکت WATSON LABS
Abbreviated New Drug Application (ANDA): 084279
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COL-PROBENECID | COLCHICINE; PROBENECID | 0.5MG;500MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/23/1976 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/084279_col-probenecid_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/06/2002 | SUPPL-45 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/25/2001 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1991 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1989 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1988 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1988 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1988 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1985 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1984 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1983 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1983 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1983 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1983 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1982 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1982 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
COL-PROBENECID
TABLET;ORAL; 0.5MG;500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COL-PROBENECID | COLCHICINE; PROBENECID | 0.5MG;500MG | TABLET;ORAL | Prescription | No | AB | 084279 | WATSON LABS |
| PROBENECID AND COLCHICINE | COLCHICINE; PROBENECID | 0.5MG;500MG | TABLET;ORAL | Prescription | No | AB | 040618 | NOVAST LABS |
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