ALLI از شرکت GLAXOSMITHKLINE CONS

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ALLI از شرکت GLAXOSMITHKLINE CONS

New Drug Application (NDA): 021887

Company: GLAXOSMITHKLINE CONS

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ALLIORLISTAT60MGCAPSULE;ORALOver-the-counter

None

YesYes
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
02/07/2007ORIG-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 DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
05/15/2017SUPPL-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

05/25/2016SUPPL-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

06/13/2014SUPPL-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

03/10/2011SUPPL-5 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021887s005ltr.pdf

02/04/2011SUPPL-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

09/22/2010SUPPL-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 DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
05/15/2017SUPPL-9

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021887Orig1s009lbl.pdf
05/25/2016SUPPL-8

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021887Orig1s008lbl.pdf
06/13/2014SUPPL-6

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021887Orig1s006lbl.pdf
02/07/2007ORIG-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 NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDApplication No.Company
ALLIORLISTAT60MGCAPSULE;ORALOver-the-counterYes021887GLAXOSMITHKLINE CONS
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