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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210868
Company: PFIZER

Products on NDA 210868

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORBRENA	LORLATINIB	25MG	TABLET;ORAL	Prescription	None	Yes	No
LORBRENA	LORLATINIB	100MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210868

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/02/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210868s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210868Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210868Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/03/2021	SUPPL-4	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210868s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210868Orig1s004ltr.pdf
02/26/2021	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210868s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210868Orig1s003ltr.pdf
01/22/2021	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210868s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210868Orig1s002ltr.pdf
05/29/2020	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210868s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210868Orig1s001ltr.pdf

Labels for NDA 210868

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/03/2021	SUPPL-4	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210868s004lbl.pdf
02/26/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210868s003lbl.pdf
01/22/2021	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210868s002lbl.pdf
05/29/2020	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210868s001lbl.pdf
11/02/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210868s000lbl.pdf

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