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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020267
Company: HALEON US HOLDINGS

Products on NDA 020267

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020267

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.

Labels for NDA 020267

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

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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	HALEON US HOLDINGS
JUNIOR STRENGTH MOTRIN	IBUPROFEN	100MG	TABLET;ORAL	Over-the-counter	No	020602	J AND J CONSUMER INC

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