Application 021891

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHILDREN'S CLARITIN	LORATADINE	TABLET, CHEWABLE;ORAL	5MG	Yes	Yes
002	CLARITIN	LORATADINE	TABLET, CHEWABLE;ORAL	10MG	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
N021891-001	CHILDREN'S CLARITIN	LORATADINE	5MG	TABLET, CHEWABLE / ORAL		RLD	2006-08-23
N021891-002	CLARITIN	LORATADINE	10MG	TABLET, CHEWABLE / ORAL		RLD, RS	2018-11-21

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	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Claritin	LORATADINE	Bayer HealthCare LLC.	37732ca2-b454-4215-91a2-c62e0f7a56af	2025-12-05	Warnings	Exact identifier application applno (NDA): 021891 application number: NDA021891 ndc (product): 11523-4331 ndc (product): 11523-4328
Claritin	LORATADINE	Bayer HealthCare LLC.	20938e05-bc3e-51aa-e054-00144ff88e88	2025-12-05		Exact identifier application applno (NDA): 021891 application number: NDA021891 ndc (product): 11523-4330
Claritin Chewable Cool Mint Flavor	LORATADINE	Bayer HealthCare LLC.	98b99bb9-d499-9ab4-e053-2a95a90a6ae6	2025-12-05	Warnings	Exact identifier application applno (NDA): 021891 application number: NDA021891 ndc (product): 11523-4364
Claritin Chewable Grape and Bubblegum	LORATADINE	Bayer HealthCare LLC.	0371368b-dca6-af2f-e063-6394a90a0ac0	2025-12-04	Warnings	Exact identifier application applno (NDA): 021891 application number: NDA021891

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11523-4328	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4328	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4328	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4328	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4328	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4328	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4330	Claritin	loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4330	Claritin	loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4330	Claritin	loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4331	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4331	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4331	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4331	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4331	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4331	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4364	Claritin Chewable	loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4364	Claritin Chewable	loratadine	Bayer HealthCare LLC.	NDA	Current
11523-4364	Claritin Chewable	loratadine	Bayer HealthCare LLC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
86010	SUPPL	2026-05-21
86006	SUPPL	2026-05-21
85768	SUPPL	2026-04-27
85761	SUPPL	2026-04-27
82297	SUPPL	2025-05-23
82103	SUPPL	2025-05-01
82021	SUPPL	2025-04-28
79692	SUPPL	2024-09-23
79691	SUPPL	2024-09-23
73070	SUPPL	2023-01-03
73059	SUPPL	2022-12-28
68142	SUPPL	2021-07-21
67210	SUPPL	2021-04-28
66991	SUPPL	2021-04-06
66479	SUPPL	2021-03-04
65870	SUPPL	2021-01-08
64244	SUPPL	2020-08-10
61234	SUPPL	2019-12-11
61233	SUPPL	2019-12-11
60247	SUPPL	2019-10-07
60246	SUPPL	2019-10-07
59109	SUPPL	2019-06-18
59108	SUPPL	2019-06-18
57121	SUPPL	2019-01-04
57118	SUPPL	2019-01-04
57053	SUPPL	2018-12-30
56723	SUPPL	2018-12-12
55110	SUPPL	2018-08-03
54945	SUPPL	2018-07-23
53020	SUPPL	2018-03-15
52696	SUPPL	2018-02-23
48536	SUPPL	2017-05-25
48524	SUPPL	2017-05-25
16527	SUPPL	2016-04-11
6396	SUPPL	2016-04-07
16526	SUPPL	2016-02-11
6395	SUPPL	2015-12-29
37833	SUPPL	2014-07-29
6394	SUPPL	2014-07-28
6393	SUPPL	2010-06-29
6392	SUPPL	2008-10-23
28790	SUPPL	2008-10-09
42340	ORIG	2008-07-09
28789	ORIG	2006-09-18
37832	ORIG	2006-09-15