Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075989
Company: PERRIGO PHARMA INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORATADINE AND PSEUDOEPHEDRINE SULFATE LORATADINE; PSEUDOEPHEDRINE SULFATE 10MG;240MG 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
03/04/2004 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075989_original_approval_pkg.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/27/2009 SUPPL-9 Labeling

Label is not available on this site.

LORATADINE AND PSEUDOEPHEDRINE SULFATE

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; 10MG;240MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLARITIN-D 24 HOUR LORATADINE; PSEUDOEPHEDRINE SULFATE 10MG;240MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 020470 BAYER HEALTHCARE LLC
LORATADINE AND PSEUDOEPHEDRINE SULFATE LORATADINE; PSEUDOEPHEDRINE SULFATE 10MG;240MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 075706 ACTAVIS LABS FL INC
LORATADINE AND PSEUDOEPHEDRINE SULFATE LORATADINE; PSEUDOEPHEDRINE SULFATE 10MG;240MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 075989 PERRIGO PHARMA INTL
LORATADINE AND PSEUDOEPHEDRINE SULFATE LORATADINE; PSEUDOEPHEDRINE SULFATE 10MG;240MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 076557 SUN PHARM INDS LTD

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