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Drugs@FDA: FDA-Approved Drugs

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

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/27/2026 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021887Orig1s013lbl.pdf
03/27/2026 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021887Orig1s013lbl.pdf
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
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