Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019658
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLARITIN LORATADINE 10MG TABLET;ORAL Over-the-counter None Yes Yes
CLARITIN HIVES RELIEF LORATADINE 10MG TABLET;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
04/12/1993 ORIG-1 Approval Type 1 - New Molecular Entity 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
02/06/2019 SUPPL-56 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019658Orig1s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019658Orig1s056ltr.pdf
12/21/2018 SUPPL-55 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/2018/019658Orig1s055,021952Orig1s018Ltr.pdf
10/03/2018 SUPPL-54 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019658Orig1s054ltr.pdf
07/05/2018 SUPPL-53 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s053lbl.pdf
05/30/2018 SUPPL-52 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019658Orig1s052ltr.pdf
05/30/2018 SUPPL-51 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019658Orig1s051ltr.pdf
01/12/2018 SUPPL-50 Labeling-Container/Carton Labels

Label is not available on this site.

04/26/2017 SUPPL-48 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019658Orig1s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019658Orig1s048ltr.pdf
12/14/2016 SUPPL-46 Labeling-Container/Carton Labels, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019658Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019658Orig1s046ltr.pdf
08/09/2016 SUPPL-45 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019658Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019658Orig1s045ltr.pdf
12/18/2015 SUPPL-44 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019658Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019658Orig1s044ltr.pdf
09/14/2015 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/05/2013 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

11/16/2012 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

12/20/2007 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019658s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019658s026_rc.pdf
06/25/2003 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658slr021ltr.pdf
11/19/2003 SUPPL-20 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
12/10/2002 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/27/2002 SUPPL-18 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
07/23/1999 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1998 SUPPL-14 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
01/27/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/08/1998 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1998 SUPPL-10 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
01/27/1998 SUPPL-9 Labeling

Label is not available on this site.

07/14/1997 SUPPL-8 Labeling

Label is not available on this site.

09/01/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1995 SUPPL-5 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19658-S005_Claritin.pdf
02/09/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/20/1995 SUPPL-3 Efficacy-New Indication

Label is not available on this site.

09/17/1993 SUPPL-2 Labeling

Label is not available on this site.

09/12/1996 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/06/2019 SUPPL-56 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019658Orig1s056lbl.pdf
12/21/2018 SUPPL-55 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s055,021952Orig1s018Lbl.pdf
10/03/2018 SUPPL-54 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s054lbl.pdf
07/05/2018 SUPPL-53 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s053lbl.pdf
05/30/2018 SUPPL-52 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s052lbl.pdf
05/30/2018 SUPPL-51 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019658Orig1s051lbl.pdf
04/26/2017 SUPPL-48 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019658Orig1s048lbl.pdf
12/14/2016 SUPPL-46 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019658Orig1s046lbl.pdf
12/14/2016 SUPPL-46 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019658Orig1s046lbl.pdf
08/09/2016 SUPPL-45 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019658Orig1s045lbl.pdf
12/18/2015 SUPPL-44 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019658Orig1s044lbl.pdf
12/20/2007 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019658s026lbl.pdf

CLARITIN

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

TABLET;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLARITIN LORATADINE 10MG TABLET;ORAL Over-the-counter Yes 019658 BAYER HEALTHCARE LLC
CLARITIN HIVES RELIEF LORATADINE 10MG TABLET;ORAL Over-the-counter Yes 019658 BAYER HEALTHCARE LLC
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 076471 APOTEX INC
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 208314 AUROBINDO PHARMA LTD
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 207569 GUARDIAN DRUG
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 075790 MYLAN
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 076154 MYLAN
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 078447 MYLAN
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 076301 PERRIGO
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 075209 PLD ACQUISITIONS LLC
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 076134 SUN PHARM INDS LTD

CLARITIN HIVES RELIEF

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

TABLET;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLARITIN LORATADINE 10MG TABLET;ORAL Over-the-counter Yes 019658 BAYER HEALTHCARE LLC
CLARITIN HIVES RELIEF LORATADINE 10MG TABLET;ORAL Over-the-counter Yes 019658 BAYER HEALTHCARE LLC
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 076471 APOTEX INC
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 208314 AUROBINDO PHARMA LTD
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 207569 GUARDIAN DRUG
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 075790 MYLAN
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 076154 MYLAN
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 078447 MYLAN
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 076301 PERRIGO
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 075209 PLD ACQUISITIONS LLC
LORATADINE LORATADINE 10MG TABLET;ORAL Over-the-counter No 076134 SUN PHARM INDS LTD

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