Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078366
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR DESLORATADINE; PSEUDOEPHEDRINE SULFATE 5MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
04/26/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078366s000ltr.pdf

DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR

TABLET, EXTENDED RELEASE;ORAL; 5MG;240MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLARINEX D 24 HOUR DESLORATADINE; PSEUDOEPHEDRINE SULFATE 5MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021605 MERCK SHARP DOHME
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR DESLORATADINE; PSEUDOEPHEDRINE SULFATE 5MG;240MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078366 DR REDDYS LABS LTD

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