Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English