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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210491
Company: VERTEX PHARMS INC

Products on NDA 210491

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYMDEKO (COPACKAGED)	IVACAFTOR; IVACAFTOR, TEZACAFTOR	150MG;150MG, 100MG	TABLET;ORAL	Prescription	None	Yes	Yes
SYMDEKO (COPACKAGED)	IVACAFTOR; IVACAFTOR, TEZACAFTOR	75MG;75MG, 50MG	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210491

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/2018	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210491lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210491Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210491Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/03/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210491s011lbl.pdf
12/21/2020	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210491s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210491Orig1s007ltr.pdf
12/27/2019	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210491Orig1s005ltr.pdf
06/21/2019	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210491Orig1s003ltr.pdf

Labels for NDA 210491

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/03/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210491s011lbl.pdf
12/21/2020	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210491s007lbl.pdf
12/27/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s005lbl.pdf
12/27/2019	SUPPL-5	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s005lbl.pdf
06/21/2019	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s003lbl.pdf
02/12/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210491lbl.pdf

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