Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 073585
Company: MCNEIL CONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUDAFED 12 HOUR PSEUDOEPHEDRINE HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter None No 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
10/31/1991 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/073585Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/15/2019 SUPPL-20 Labeling-Proprietary Name Change

Label is not available on this site.

11/14/2018 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

11/06/2001 SUPPL-14 Labeling

Label is not available on this site.

09/11/2000 SUPPL-13 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/12/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/12/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/12/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/12/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/12/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/12/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/12/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/12/1999 SUPPL-5 Labeling

Label is not available on this site.

01/31/1997 SUPPL-4 Labeling

Label is not available on this site.

SUDAFED 12 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; 120MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 209008 AUROBINDO PHARMA LTD
PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 075153 L PERRIGO CO
PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 077442 SUN PHARM INDS LTD
SUDAFED 12 HOUR PSEUDOEPHEDRINE HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 073585 MCNEIL CONS

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