Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021993
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLARITIN REDITABS LORATADINE 5MG TABLET, ORALLY DISINTEGRATING;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
12/12/2006 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021993s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021993s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021993_claritin_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2019 SUPPL-17 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020704Orig1s034,021993Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020704Orig1s034, 021993Orig1s017ltr.pdf
07/23/2018 SUPPL-16 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021993Orig1s016,020704Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021993Orig1s016,020704Orig1s033ltr.pdf
11/25/2015 SUPPL-13 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021993Orig1s013, 020704Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021993Orig1s013,020704Orig1s028ltr.pdf
07/22/2014 SUPPL-12 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020704Orig1s027, 021993Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020704Orig1s027,021993Orig1s012ltr.pdf
10/21/2008 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021993s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/28/2019 SUPPL-17 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020704Orig1s034,021993Orig1s017lbl.pdf
07/23/2018 SUPPL-16 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021993Orig1s016,020704Orig1s033lbl.pdf
11/25/2015 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021993Orig1s013, 020704Orig1s028lbl.pdf
07/22/2014 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020704Orig1s027, 021993Orig1s012lbl.pdf
12/12/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021993s000lbl.pdf

CLARITIN REDITABS

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

TABLET, ORALLY DISINTEGRATING;ORAL; 5MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLARITIN REDITABS LORATADINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter Yes 021993 BAYER HEALTHCARE LLC

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