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
CATAFLAM از شرکت AMICI
Abbreviated New Drug Application (ANDA): 076561
Company: AMICI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CATAFLAM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CATAFLAM | DICLOFENAC POTASSIUM | 25MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 03/18/2004 | 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 |
|---|---|---|---|---|---|
| 05/17/2021 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/29/2021 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/12/2021 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/17/2021 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/17/2021 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/12/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/17/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
CATAFLAM
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CATAFLAM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 076561 | AMICI |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 075463 | RK PHARMA |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 075229 | RUBICON |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 075219 | TEVA |
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CATAFLAM | DICLOFENAC POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 076561 | AMICI |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 075229 | RUBICON |
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