ADVIL LIQUI-GELS از شرکت GLAXOSMITHKLINE

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

ADVIL LIQUI-GELS از شرکت GLAXOSMITHKLINE

New Drug Application (NDA): 020402

Company: GLAXOSMITHKLINE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVIL LIQUI-GELS IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter

None

Yes Yes
ADVIL MIGRAINE LIQUI-GELS IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT 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
04/20/1995 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2018 SUPPL-47 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020402Orig1s047lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020402Orig1s047ltr.pdf

08/02/2018 SUPPL-46 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020402Orig1s046lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020402Orig1s046Ltr.pdf

10/18/2017 SUPPL-44

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020402Orig1s044ltr.pdf

08/08/2017 SUPPL-43 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020402Orig1s043lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020402Orig1s043ltr.pdf

03/08/2017 SUPPL-42 Manufacturing (CMC)-Control

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020402s042lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020402Orig1s042ltr.pdf

12/17/2015 SUPPL-40 Manufacturing (CMC)

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020402Orig1s040lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020402Orig1s040ltr.pdf

09/12/2014 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

12/11/2012 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

12/05/2012 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/20/2011 SUPPL-27 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020402Orig1s027lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020402s027ltr.pdf

07/09/2009 SUPPL-26 Labeling-Package Insert, Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020402s026ltr.pdf

05/19/2009 SUPPL-25 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020402s025ltr.pdf

06/11/2008 SUPPL-24 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020402s024ltr.pdf

02/08/2006 SUPPL-18 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020402s018ltr.pdf

04/28/2006 SUPPL-16 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020402s016LTR.pdf

02/26/2004 SUPPL-11 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20402slr011ltr.pdf

08/02/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/28/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/2000 SUPPL-5 Efficacy-New Indication

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20402S5LBL.PDF

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20402S5LTR.PDF

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-402-s005_Advil.cfm

04/09/1999 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1999 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/23/1998 SUPPL-2 Labeling

Label is not available on this site.

10/06/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/31/2018 SUPPL-47

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020402Orig1s047lbl.pdf
08/02/2018 SUPPL-46

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020402Orig1s046lbl.pdf
08/08/2017 SUPPL-43

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020402Orig1s043lbl.pdf
03/08/2017 SUPPL-42

Manufacturing (CMC)-Control

Label (PDF)

This supplement type does not usually require new labeling.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020402s042lbl.pdf
12/17/2015 SUPPL-40

Manufacturing (CMC)

Label (PDF)

This supplement type does not usually require new labeling.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020402Orig1s040lbl.pdf
04/20/2011 SUPPL-27

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020402Orig1s027lbl.pdf
03/16/2000 SUPPL-5

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20402S5LBL.PDF

ADVIL LIQUI-GELS

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

CAPSULE;ORAL; EQ 200MG FREE ACID AND POTASSIUM SALT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL LIQUI-GELS IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter Yes 020402 GLAXOSMITHKLINE
ADVIL MIGRAINE LIQUI-GELS IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter Yes 020402 GLAXOSMITHKLINE
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 202300 AMNEAL PHARMS
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 206999 ASCENT PHARMS INC
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 207753 AUROBINDO PHARMA LTD
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 078682 BIONPHARMA INC
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 206568 HUMANWELL PURACAP
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 079205 MARKSANS PHARMA
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 077338 P AND L DEV LLC
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 203599 SOFGEN PHARMS

ADVIL MIGRAINE LIQUI-GELS

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

CAPSULE;ORAL; EQ 200MG FREE ACID AND POTASSIUM SALT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL LIQUI-GELS IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter Yes 020402 GLAXOSMITHKLINE
ADVIL MIGRAINE LIQUI-GELS IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter Yes 020402 GLAXOSMITHKLINE
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 202300 AMNEAL PHARMS
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 206999 ASCENT PHARMS INC
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 207753 AUROBINDO PHARMA LTD
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 078682 BIONPHARMA INC
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 206568 HUMANWELL PURACAP
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 079205 MARKSANS PHARMA
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 077338 P AND L DEV LLC
IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 203599 SOFGEN PHARMS
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