Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020402
Company: PFIZER
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
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-Container/Carton Labels, Labeling-Package Insert 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
08/08/2017 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 PFIZER
ADVIL MIGRAINE LIQUI-GELS IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter Yes 020402 PFIZER
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 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 PFIZER
ADVIL MIGRAINE LIQUI-GELS IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter Yes 020402 PFIZER
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 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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