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CASODEX از شرکت ANI PHARMS

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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

Review (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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
بخوانید  CASODEX از شرکت ASTRAZENECA
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