Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020641
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLARITIN LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter None Yes Yes
CLARITIN HIVES RELIEF LORATADINE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None Yes No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
10/10/1996 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-46 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020641Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020641Orig1s046ltr.pdf
05/14/2018 SUPPL-45 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020641Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020641Orig1s045ltr.pdf
08/09/2016 SUPPL-42 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020641Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020641Orig1s042ltr.pdf
02/12/2016 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

12/30/2015 SUPPL-40 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s040ltr.pdf
12/10/2015 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/12/2015 SUPPL-38 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s038ltr.pdf
10/21/2015 SUPPL-37 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s037ltr.pdf
04/16/2015 SUPPL-36 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s036ltr.pdf
05/15/2014 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/16/2013 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/28/2013 SUPPL-32 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020641Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020641Orig1s032ltr.pdf
11/20/2012 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/25/2008 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020641s025ltr.pdf
07/25/2008 SUPPL-24 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020641s024ltr.pdf
06/14/2005 SUPPL-18 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020641s018ltr.pdf
10/27/2004 SUPPL-17 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20641s017ltr.pdf
07/15/2004 SUPPL-16 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20641s016ltr.pdf
12/09/2002 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/19/2003 SUPPL-11 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
07/23/2002 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/27/2002 SUPPL-9 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
12/04/2000 SUPPL-7 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20641s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-641S007_Loratadine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-641s007_LoratadineClaritin.cfm
01/07/1999 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/29/1998 SUPPL-3 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
03/30/1998 SUPPL-2 Labeling

Label is not available on this site.

01/23/1998 SUPPL-1 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/28/2019 SUPPL-46 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020641Orig1s046lbl.pdf
05/14/2018 SUPPL-45 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020641Orig1s045lbl.pdf
08/09/2016 SUPPL-42 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020641Orig1s042lbl.pdf
12/30/2015 SUPPL-40 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s040lbl.pdf
11/12/2015 SUPPL-38 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s038lbl.pdf
10/21/2015 SUPPL-37 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641s037lbl.pdf
04/16/2015 SUPPL-36 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s036lbl.pdf
02/28/2013 SUPPL-32 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020641Orig1s032lbl.pdf
12/04/2000 SUPPL-7 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20641s7lbl.pdf

CLARITIN

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

SYRUP;ORAL; 1MG/ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLARITIN LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter Yes 020641 BAYER HEALTHCARE LLC
LORATADINE LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter No 208931 AUROBINDO PHARMA LTD
LORATADINE LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter No 077421 LANNETT CO INC
LORATADINE LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter No 075728 PERRIGO
LORATADINE LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter No 076805 TARO
LORATADINE LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter No 201865 TARO PHARM
LORATADINE LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter No 075505 TEVA
LORATADINE LORATADINE 1MG/ML SYRUP;ORAL Over-the-counter No 075815 WOCKHARDT BIO AG

CLARITIN HIVES RELIEF

There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.

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