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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019899
Company: J AND J CONSUMER INC

Products on NDA 019899

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SINE-AID IB	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019899

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/1992	ORIG-1	Approval	Type 4 - New Combination	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
12/01/2021	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019899Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019899Orig1s020ltr.pdf
05/15/2017	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019899Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019899Orig1s019ltr.pdf
02/27/2006	SUPPL-18	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019899s018ltr.pdf
07/29/2003	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19899slr015_motrin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19899slr015ltr.pdf
05/02/2001	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
09/03/2002	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19899slr008,011,012ltr.pdf
09/03/2002	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19899slr008,011,012ltr.pdf
11/29/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/06/2000	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
09/03/2002	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19899slr008,011,012ltr.pdf
06/14/1994	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
07/29/1993	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/13/1993	SUPPL-1	Manufacturing (CMC)-Formulation		Label is not available on this site.

Labels for NDA 019899

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/01/2021	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019899Orig1s020lbl.pdf
05/15/2017	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019899Orig1s019lbl.pdf
07/29/2003	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19899slr015_motrin_lbl.pdf

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

SINE-AID IB

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

TABLET;ORAL; 200MG;30MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ADVIL COLD AND SINUS	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET;ORAL	Over-the-counter	Yes	019771	HALEON US HOLDINGS
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET;ORAL	Over-the-counter	No	077628	DR REDDYS LABS LTD
IBUPROHM COLD AND SINUS	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET;ORAL	Over-the-counter	No	074567	OHM LABS
SINE-AID IB	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET;ORAL	Over-the-counter	No	019899	J AND J CONSUMER INC

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