Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019670
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLARITIN-D LORATADINE; PSEUDOEPHEDRINE SULFATE 5MG;120MG TABLET, EXTENDED RELEASE;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
11/14/1994 ORIG-1 Approval Type 4 - New Combination 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
07/31/2018 SUPPL-34 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019670Orig1s034,020470Orig1s047Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019670Orig1s034,020470Orig1s047ltr.pdf
11/25/2015 SUPPL-32 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019670Orig1s032, 020470Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019670Orig1s032,020470Orig1s044ltr.pdf
10/18/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/13/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/25/2010 SUPPL-22 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019670s22,020470s034ltr.pdf
04/23/2009 SUPPL-20 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019670s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/019670Orig1s020.pdf
07/30/2004 SUPPL-19 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19670s019,20470s022ltr.pdf
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/2002/19670se6-018,20470se6-016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm
03/04/2002 SUPPL-17 Manufacturing (CMC)-Expiration Date Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019670_S017_Claritin-DTOC.cfml
11/01/2000 SUPPL-15 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s015,018506s022_Claritin-DTOC.cfml
03/22/2000 SUPPL-14 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s014_Claritin-DTOC.cfml
09/13/2000 SUPPL-13 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s013,20470s10,18506s018_Claritin-DTOC.cfml
10/29/1998 SUPPL-12 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
04/29/1998 SUPPL-10 Labeling

Label is not available on this site.

01/27/1999 SUPPL-9 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/019670_s009_Claritin-DTOC.cfml
01/23/1998 SUPPL-8 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
05/04/1998 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1997 SUPPL-6 Labeling

Label is not available on this site.

07/21/1997 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1997 SUPPL-4 Labeling

Label is not available on this site.

04/29/1996 SUPPL-3 Labeling

Label is not available on this site.

09/22/1995 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1997 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/31/2018 SUPPL-34 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019670Orig1s034,020470Orig1s047Lbl.pdf
11/25/2015 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019670Orig1s032, 020470Orig1s044lbl.pdf
07/30/2004 SUPPL-19 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf

CLARITIN-D

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

TABLET, EXTENDED RELEASE;ORAL; 5MG;120MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CLARITIN-D LORATADINE; PSEUDOEPHEDRINE SULFATE 5MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 019670 BAYER HEALTHCARE LLC
LORATADINE AND PSEUDOEPHEDRINE SULFATE LORATADINE; PSEUDOEPHEDRINE SULFATE 5MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 076050 PERRIGO PHARMA INTL

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English