Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075153
Company: L PERRIGO CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/26/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75153ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/24/2011 SUPPL-34 Labeling-Container/Carton Labels

Label is not available on this site.

04/20/2005 SUPPL-17 Labeling

Label is not available on this site.

12/09/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

12/12/2001 SUPPL-8 Labeling

Label is not available on this site.

10/22/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/2002 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/07/2002 SUPPL-5 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

04/17/2001 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

04/17/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

PSEUDOEPHEDRINE HYDROCHLORIDE

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

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