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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206333
Company: KYTHERA BIOPHARMS

Summary Review

Products on NDA 206333

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KYBELLA	DEOXYCHOLIC ACID	20MG/2ML (10MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206333

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206333Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206333Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206333Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206333Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/05/2022	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206333s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206333Orig1s005ltr.pdf
05/20/2020	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206333s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206333Orig1s002, s003ltr.pdf
05/20/2020	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206333s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206333Orig1s002, s003ltr.pdf
01/18/2018	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206333s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206333Orig1s001ltr.pdf

Labels for NDA 206333

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/05/2022	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206333s005lbl.pdf
05/20/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206333s002s003lbl.pdf
05/20/2020	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206333s002s003lbl.pdf
05/20/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206333s002s003lbl.pdf
05/20/2020	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206333s002s003lbl.pdf
01/18/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206333s001lbl.pdf
04/29/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206333Orig1s000lbl.pdf

Therapeutic Equivalents for NDA 206333

KYBELLA

SOLUTION;SUBCUTANEOUS; 20MG/2ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEOXYCHOLIC ACID	DEOXYCHOLIC ACID	20MG/2ML (10MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	212296	SLAYBACK PHARMA LLC
KYBELLA	DEOXYCHOLIC ACID	20MG/2ML (10MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	Yes	AP	206333	KYTHERA BIOPHARMS

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