Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019670
Company: BAYER HEALTHCARE LLC
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 |
|---|---|---|---|---|---|
| 11/09/2023 | SUPPL-36 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019670Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019670Orig1s036ltr.pdf | |
| 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-Container/Carton Labels, Labeling-Package Insert |
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 |
|---|---|---|---|---|---|
| 11/09/2023 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019670Orig1s036lbl.pdf | |
| 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 |