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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021887
Company: HALEON US HOLDINGS

Products on NDA 021887

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALLI	ORLISTAT	60MG	CAPSULE;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021887

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/2007	ORIG-1	Approval	Type 8 - Partial Rx to OTC Switch	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021887lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021887s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021887s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/15/2017	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021887Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021887Orig1s009ltr.pdf
05/25/2016	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021887Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021887Orig1s008ltr.pdf
06/13/2014	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021887Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021887Orig1s006ltr.pdf
03/10/2011	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021887s005ltr.pdf
02/04/2011	SUPPL-4	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021887s004ltr.pdf
09/22/2010	SUPPL-2	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021887s002ltr.pdf

Labels for NDA 021887

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/15/2017	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021887Orig1s009lbl.pdf
05/25/2016	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021887Orig1s008lbl.pdf
06/13/2014	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021887Orig1s006lbl.pdf
02/07/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021887lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

ALLI

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE;ORAL; 60MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ALLI	ORLISTAT	60MG	CAPSULE;ORAL	Over-the-counter	Yes	021887	HALEON US HOLDINGS

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