Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075706
Company: P AND L
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
02/21/2003 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/75706_Loratadine And Pseudoephedrine Sulfate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75706_Loratadine And Pseudoephedrine Sulfate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/075706_loratadine-pseudoephedrine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/26/2004 SUPPL-6 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/21/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/75706_Loratadine And Pseudoephedrine Sulfate_Prntlbl.pdf

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 P AND L
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

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