Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021952
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLARITIN LORATADINE 10MG CAPSULE;ORAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/16/2008 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021952s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021952_claritin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021952s000_SUMR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/21/2018 SUPPL-18 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s055,021952Orig1s018Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019658Orig1s055,021952Orig1s018Ltr.pdf
07/20/2018 SUPPL-17 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s017Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021952Orig1s017Ltr.pdf
06/20/2018 SUPPL-16 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021952Orig1s016ltr.pdf
06/04/2018 SUPPL-15 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021952Orig1s015ltr.pdf
04/18/2018 SUPPL-14 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021952Orig1s014ltr.pdf
12/09/2015 SUPPL-12 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021952Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021952Orig1s012ltr.pdf
04/06/2009 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021952s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/21/2018 SUPPL-18 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s055,021952Orig1s018Lbl.pdf
07/20/2018 SUPPL-17 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s017Lbl.pdf
06/20/2018 SUPPL-16 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s016lbl.pdf
06/04/2018 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s015lbl.pdf
04/18/2018 SUPPL-14 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021952Orig1s014lbl.pdf
12/09/2015 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021952Orig1s012lbl.pdf

CLARITIN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLARITIN LORATADINE 10MG CAPSULE;ORAL Over-the-counter Yes 021952 BAYER HEALTHCARE LLC
LORATADINE LORATADINE 10MG CAPSULE;ORAL Over-the-counter No 206214 MARKSANS PHARMA

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