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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021128
Company: J AND J CONSUMER INC

Products on NDA 021128

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHILDREN'S MOTRIN COLD	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	100MG/5ML;15MG/5ML	SUSPENSION;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021128

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/01/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-128_ChildrensMotrin.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2017	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021228Orig1s010lbl.pdf
04/29/2009	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021128s009ltr.pdf
12/21/2005	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021128s007ltr.pdf
04/20/2005	SUPPL-6	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021128s006ltr.pdf
12/19/2003	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20516slr012,21128slr003ltr.pdf
05/02/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 021128

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2017	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021228Orig1s010lbl.pdf

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

CHILDREN'S MOTRIN COLD

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

SUSPENSION;ORAL; 100MG/5ML;15MG/5ML

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CHILDREN'S ADVIL COLD	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	100MG/5ML;15MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	021373	HALEON US HOLDINGS
CHILDREN'S MOTRIN COLD	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	100MG/5ML;15MG/5ML	SUSPENSION;ORAL	Over-the-counter	Yes	021128	J AND J CONSUMER INC

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