Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020704
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLARITIN HIVES RELIEF REDITAB LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter None Yes Yes
CLARITIN REDITABS LORATADINE 10MG 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
12/23/1996 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2019 SUPPL-34 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-33 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
05/16/2017 SUPPL-32 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020704Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020704Orig1s032ltr.pdf
11/04/2016 SUPPL-29 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020704Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020704Orig1s029ltr.pdf
11/25/2015 SUPPL-28 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-27 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
01/29/2009 SUPPL-21 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020704s021ltr.pdf
10/21/2008 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020704s020ltr.pdf
01/19/2006 SUPPL-14 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020704s014ltr.pdf
11/19/2003 SUPPL-9 Efficacy-Rx To OTC Switch Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658se6-020,20704se6-009,20641se6-011ltr.pdf
11/27/2002 SUPPL-8 Efficacy-Rx To OTC Switch Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19658se6-018,20704se6-008,20641se6-009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm
09/18/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1998 SUPPL-4 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s012,19658s14,20470s7,20641s3,20704s4_ClaritinDTOC.cfml
01/23/1998 SUPPL-3 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s008,19658s10,20470s3,20641s120704s3_Claritin-DTOC.cfml
09/19/1997 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1998 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/28/2019 SUPPL-34 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020704Orig1s034,021993Orig1s017lbl.pdf
07/23/2018 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021993Orig1s016,020704Orig1s033lbl.pdf
05/16/2017 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020704Orig1s032lbl.pdf
11/04/2016 SUPPL-29 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020704Orig1s029lbl.pdf
11/25/2015 SUPPL-28 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021993Orig1s013, 020704Orig1s028lbl.pdf
07/22/2014 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020704Orig1s027, 021993Orig1s012lbl.pdf

CLARITIN HIVES RELIEF REDITAB

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; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALAVERT LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 021375 PFIZER
CLARITIN HIVES RELIEF REDITAB LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter Yes 020704 BAYER HEALTHCARE LLC
CLARITIN REDITABS LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter Yes 020704 BAYER HEALTHCARE LLC
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 075990 ACTAVIS LABS FL INC
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 208477 AUROBINDO PHARMA LTD
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 076011 PERRIGO PHARMA INTL
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 075822 PFIZER
LORATADINE REDIDOSE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 077153 SUN PHARM INDS LTD

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; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALAVERT LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 021375 PFIZER
CLARITIN HIVES RELIEF REDITAB LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter Yes 020704 BAYER HEALTHCARE LLC
CLARITIN REDITABS LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter Yes 020704 BAYER HEALTHCARE LLC
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 075990 ACTAVIS LABS FL INC
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 208477 AUROBINDO PHARMA LTD
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 076011 PERRIGO PHARMA INTL
LORATADINE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 075822 PFIZER
LORATADINE REDIDOSE LORATADINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 077153 SUN PHARM INDS LTD

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