Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076050
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 5MG;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
01/30/2003 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/76050APltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076050Orig1Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/21/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/21/2005 SUPPL-11 Labeling

Label is not available on this site.

09/22/2004 SUPPL-7 Labeling

Label is not available on this site.

07/28/2004 SUPPL-5 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; 5MG;120MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLARITIN-D LORATADINE; PSEUDOEPHEDRINE SULFATE 5MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 019670 BAYER HEALTHCARE LLC
LORATADINE AND PSEUDOEPHEDRINE SULFATE LORATADINE; PSEUDOEPHEDRINE SULFATE 5MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 076050 PERRIGO PHARMA INTL

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