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
CASODEX از شرکت ANI PHARMS
New Drug Application (NDA): 020498
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CASODEX | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription |
AB |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 10/04/1995 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020498Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/01/2017 | SUPPL-28 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020498s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020498Orig1s028ltr.pdf |
||
| 03/17/2017 | SUPPL-27 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020498s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020498Orig1s027ltr.pdf |
||
| 02/27/2015 | SUPPL-25 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020498s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020498Orig1s025ltr.pdf |
||
| 09/12/2013 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/2010 | SUPPL-22 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020498s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020498s022ltr.pdf |
||
| 03/13/2009 | SUPPL-21 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020498s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020498s019,s021ltr.pdf |
||
| 03/13/2009 | SUPPL-19 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020498s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020498s019,s021ltr.pdf |
||
| 03/10/2006 | SUPPL-18 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020498s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020498s018ltr.pdf |
||
| 05/11/2005 | SUPPL-16 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020498s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020498s016ltr.pdf |
||
| 09/23/2002 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/25/2001 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/11/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1997 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
||
| 11/12/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/01/2017 | SUPPL-28 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020498s028lbl.pdf | |
| 03/17/2017 | SUPPL-27 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020498s027lbl.pdf | |
| 02/27/2015 | SUPPL-25 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020498s025lbl.pdf | |
| 09/15/2010 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020498s022lbl.pdf | |
| 03/13/2009 | SUPPL-21 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020498s019s021lbl.pdf | |
| 03/13/2009 | SUPPL-19 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020498s019s021lbl.pdf | |
| 03/10/2006 | SUPPL-18 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020498s018lbl.pdf | |
| 05/11/2005 | SUPPL-16 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020498s016lbl.pdf |
CASODEX
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 078917 | ACCORD HLTHCARE |
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 200274 | APOTEX INC |
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 091011 | KENTON |
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 078575 | SANDOZ |
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 079110 | SUN PHARM |
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 078634 | WATSON LABS TEVA |
| BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 079089 | ZYDUS PHARMS USA INC |
| CASODEX | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 020498 | ANI PHARMS |
نظرات کاربران