Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021887
Company: GLAXOSMITHKLINE CONS
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
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
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

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 GLAXOSMITHKLINE CONS

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