BENDAMUSTINE HYDROCHLORIDE از شرکت ACCORD HLTHCARE

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): 205574

Company: ACCORD HLTHCARE

Products on ANDA 205574

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	AP	No	No
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205574

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/2020	ORIG-1	Tentative Approval		STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205574Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205574Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205574Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205574Orig1s000TA_ltr.pdf

Action Date

Submission

Action Type

Submission Classification

Review Priority; Orphan Status

Letters, Reviews, Labels, Patient Package Insert

Notes

Url

09/21/2020

ORIG-1

Tentative Approval

STANDARD

Label (PDF)

Letter (PDF)

Letter (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205574Orig1s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205574Orig1s000TAltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205574Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205574Orig1s000TA_ltr.pdf

Labels for ANDA 205574

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/21/2020	ORIG-1	Tentative Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205574Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 205574

BENDAMUSTINE HYDROCHLORIDE

POWDER;IV (INFUSION); 25MG/VIAL

TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	25MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	205574	ACCORD HLTHCARE

POWDER;IV (INFUSION); 100MG/VIAL

TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE	100MG/VIAL	POWDER;IV (INFUSION)	Prescription	No	AP	205574	ACCORD HLTHCARE

حتما بخوانید : CAPECITABINE از شرکت ACCORD HLTHCARE

منبع : www.accessdata.fda.gov

بخوانید BENDAMUSTINE HYDROCHLORIDE از شرکت SLAYBACK PHARMA LLC

BENDAMUSTINE HYDROCHLORIDE از شرکت ACCORD HLTHCARE