Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206088
Company: CELGENE CORP

• Summary Review

Products on NDA 206088

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OTEZLA	APREMILAST	10MG	TABLET;ORAL	Prescription	TBD	TBD	No
OTEZLA	APREMILAST	20MG	TABLET;ORAL	Prescription	TBD	TBD	No
OTEZLA	APREMILAST	30MG	TABLET;ORAL	Prescription	TBD	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206088

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/2014	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206088s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206088Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206088Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206088Orig1s000SumR.pdf

Labels for NDA 206088

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206088s000lbl.pdf

Therapeutic Equivalents for NDA 206088

OTEZLA

There are no Therapeutic Equivalents.