Application 020641

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	CLARITIN	LORATADINE	SYRUP;ORAL	1MG/ML	Yes	Yes
003	CLARITIN HIVES RELIEF	LORATADINE	SYRUP;ORAL	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020641-002	CLARITIN	LORATADINE	1MG/ML	SYRUP / ORAL		RLD, RS	2002-11-27
N020641-003	CLARITIN HIVES RELIEF	LORATADINE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	2003-11-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	2003-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	2003-11-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	2003-11-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	2003-11-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	2003-11-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	2003-11-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	2003-11-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	2003-11-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	2003-11-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`3a93d1ddd44b…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Claritin Allergy	LORATADINE	Bayer HealthCare LLC.	19afd658-8c67-af44-e063-6394a90abada	2025-12-04	Warnings	Exact identifier application applno (NDA): 020641 application number: NDA020641
Children Claritin Allergy	LORATADINE	Bayer HealthCare LLC.	170061e9-e529-4ff0-e054-00144ff8d46c	2025-05-15	Warnings	Exact identifier application applno (NDA): 020641 application number: NDA020641 ndc (product): 11523-4360

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11523-4360	Children Claritin	loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4360	Children Claritin	loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4360	Children Claritin	loratadine	Bayer HealthCare LLC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80586	SUPPL	2024-12-16
80585	SUPPL	2024-12-16
57865	SUPPL	2019-03-01
57855	SUPPL	2019-03-01
54314	SUPPL	2018-05-23
54218	SUPPL	2018-05-16
45089	SUPPL	2016-08-22
45033	SUPPL	2016-08-09
12919	SUPPL	2016-01-04
2992	SUPPL	2015-12-31
35067	SUPPL	2015-11-25
2991	SUPPL	2015-11-09
35066	SUPPL	2015-10-26
25433	SUPPL	2015-10-23
2990	SUPPL	2015-04-22
12918	SUPPL	2015-04-21
35065	SUPPL	2014-01-14
2989	SUPPL	2013-03-01
25432	SUPPL	2008-07-30
25431	SUPPL	2008-07-30
41517	SUPPL	2007-03-02
20803	SUPPL	2007-03-02
2988	SUPPL	2005-06-15
41518	SUPPL	2004-12-07
2987	SUPPL	2004-10-29
25430	SUPPL	2004-07-21
25429	SUPPL	2003-11-25
25428	SUPPL	2002-11-27
20804	SUPPL	2000-12-04
12917	SUPPL	2000-12-04
2986	SUPPL	2000-12-04