BICALUTAMIDE از شرکت TEVA

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

Abbreviated New Drug Application (ANDA): 076932

Company: TEVA

Products on ANDA 076932

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076932

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/06/2009	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/076932s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076932s000ltr.pdf

Action Date

Submission

Action Type

Submission Classification

Review Priority; Orphan Status

Letters, Reviews, Labels, Patient Package Insert

Notes

Url

07/06/2009

ORIG-1

Approval

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/076932s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076932s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Note
03/20/2020	SUPPL-8	Labeling-Package Insert	Label is not available on this site.
03/20/2020	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert	Label is not available on this site.
04/19/2016	SUPPL-5	Labeling-Package Insert	Label is not available on this site.
12/12/2013	SUPPL-4	Labeling-Package Insert	Label is not available on this site.
05/08/2011	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert	Label is not available on this site.