Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020267
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JUNIOR STRENGTH ADVIL IBUPROFEN 100MG TABLET;ORAL Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/13/1996 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
03/29/2017 SUPPL-15 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020267Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020267Orig1s015ltr.pdf
05/19/2009 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020267s013ltr.pdf
06/20/2008 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020267s012ltr.pdf
01/17/2006 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020267s010ltr.pdf
08/30/2004 SUPPL-9 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20267s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020267Orig1s009.pdf
08/02/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/2000 SUPPL-5 Labeling

Label is not available on this site.

10/14/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/08/1999 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/30/1998 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/20/1998 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
03/29/2017 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020267Orig1s015lbl.pdf

JUNIOR STRENGTH ADVIL

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

TABLET;ORAL; 100MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
JUNIOR STRENGTH ADVIL IBUPROFEN 100MG TABLET;ORAL Over-the-counter No 020267 PFIZER
JUNIOR STRENGTH IBUPROFEN IBUPROFEN 100MG TABLET;ORAL Over-the-counter No 075367 L PERRIGO CO
JUNIOR STRENGTH MOTRIN IBUPROFEN 100MG TABLET;ORAL Over-the-counter No 020602 J AND J CONSUMER INC

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