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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207987
Company: BPI LABS

Products on NDA 207987

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ABLYSINOL	DEHYDRATED ALCOHOL	99% (1ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRA-ARTERIAL	Discontinued	None	Yes	No
ABLYSINOL	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION;INTRA-ARTERIAL	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207987

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207987lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207987Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207987Orig1s000TOC.html

Labels for NDA 207987

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207987lbl.pdf

Therapeutic Equivalents for NDA 207987

ABLYSINOL

SOLUTION;INTRA-ARTERIAL; 99% (5ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ABLYSINOL	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION;INTRA-ARTERIAL	Prescription	Yes	AP	207987	BPI LABS
DEHYDRATED ALCOHOL	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION;INTRA-ARTERIAL	Prescription	No	AP	217845	ACCORD HLTHCARE
DEHYDRATED ALCOHOL	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION;INTRA-ARTERIAL	Prescription	No	AP	219444	BRECKENRIDGE
DEHYDRATED ALCOHOL	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION;INTRA-ARTERIAL	Prescription	No	AP	219569	INGENUS PHARMS LLC
DEHYDRATED ALCOHOL	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION;INTRA-ARTERIAL	Prescription	No	AP	219400	XGEN PHARMS

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