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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020021
Company: J AND J CONSUMER INC

Products on NDA 020021

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUDAFED 24 HOUR	PSEUDOEPHEDRINE HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020021

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/1992	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
11/13/2018	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020021Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020021Orig1s012ltr.pdf
12/21/2017	SUPPL-11	Labeling-Container/Carton Labels		Label is not available on this site.
10/24/2001	SUPPL-6	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020021_S006_SUDAFED_AP.pdf
03/28/2001	SUPPL-5	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020021_S005_SUDAFED_AP.pdf
08/05/1998	SUPPL-4	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/020021_S004_EFIDAC_AP.pdf
05/09/1995	SUPPL-3	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20021_S003_EFIDAC 24_AP.pdf
05/21/1993	SUPPL-2	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20021_S002_EFIDAC 24_AP.pdf
02/01/1993	SUPPL-1	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20021_S001_EFIDAC 24_AP.pdf

Labels for NDA 020021

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/13/2018	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020021Orig1s012lbl.pdf

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

SUDAFED 24 HOUR

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

TABLET, EXTENDED RELEASE;ORAL; 240MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
SUDAFED 24 HOUR	PSEUDOEPHEDRINE HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	Yes	020021	J AND J CONSUMER INC

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