Application 021952

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLARITIN	LORATADINE	CAPSULE;ORAL	10MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021952-001	CLARITIN	LORATADINE	10MG	CAPSULE / ORAL		RLD, RS	2008-06-16

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`f41ea6bd6efb…`

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 15 of 17 · 339 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dye-Free Childrens Loratadine	LORATADINE	RITE AID	322d9a03-a908-4858-b25e-6eba2411fa03	2022-06-02	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	AAA PHARMACEUTICAL, INC.	9c8535e3-6a60-4640-b37e-a2260936d9af	2022-04-21	Warnings	Name fallback generic name: LORATADINE
signature care allergy relief	LORATADINE	Safeway	0a4b8eef-762e-42cc-84ee-0018a9a3be58	2022-04-04	Warnings	Name fallback generic name: LORATADINE
Loratadine antihistamine	LORATADINE	Proficient Rx LP	e9b87f79-ebed-4677-8e50-00cb4282ee56	2022-04-01	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Rising Pharmaceuticals, Inc	d28128a3-af54-440e-9bd4-0fccf393d18a	2022-03-10	Warnings	Name fallback generic name: LORATADINE
topcare childrens allergy	LORATADINE	Topco Associates LLC	6e175fae-05dd-45c2-b9ab-7d49369a3c05	2022-02-28	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	SAFEWAY INC.	1092b8af-25f2-4c25-b3bc-5ffb14e96024	2021-12-21	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	CVS Pharmacy	e63f082c-ff50-43ed-ad2c-598b352413e8	2021-12-21	Warnings	Name fallback generic name: LORATADINE
Topcare Allergy Relief	LORATADINE	Topco Associates LLC	32f4e1d1-c830-4752-8251-bcc233bf03f6	2021-11-29	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	MARKSANS PHARMA LIMITED	c30907f9-1761-41e5-bd4e-2613e756e1c6	2021-11-15	Warnings	Name fallback generic name: LORATADINE
careone allergy relief	LORATADINE	American Sales Company	fdacfd88-eb85-4a33-9863-c6ff484fea4e	2021-11-15	Warnings	Name fallback generic name: LORATADINE
Childrens Allergy Relief	LORATADINE	H E B	704ee04d-6bdd-4d0a-ba24-2a9fd79a90fb	2021-08-24	Warnings	Name fallback generic name: LORATADINE
Basic Care Childrens Allergy Relief	LORATADINE	Amazon.com Services LLC	e2c83874-aa95-477a-9cfd-cecfd776ba0e	2021-08-12	Warnings	Name fallback generic name: LORATADINE
good sense allergy relief	LORATADINE	L. Perrigo Company	a8f97128-3af8-493d-8e66-a1e07f594131	2021-07-14	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	DISCOUNT DRUG MART	c29bf35f-1f19-c3c9-e053-2995a90ac1b6	2021-07-12	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Cardinal Health, 110 dba LEADER	db9d2182-6bf1-424a-a144-f2694c47989f	2021-06-23	Warnings	Name fallback generic name: LORATADINE
dg health allergy relief	LORATADINE	Dolgencorp, LLC	c18c40ae-19c8-4699-842a-43a5c4c236d5	2021-06-22	Warnings	Name fallback generic name: LORATADINE
welby all day allergy relief	LORATADINE	Aldi, Inc	efe2fa11-8115-4d33-bb32-8e2509839ef4	2021-06-22	Warnings	Name fallback generic name: LORATADINE
leader childrens allergy relief	LORATADINE	Cardinal Health 110, LLC. dba Leader	20b438e1-f461-48fa-b007-4c02ecb91b68	2021-06-17	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	HARRIS TEETER	b8f67f52-906e-c7a8-e053-2995a90a5cbd	2021-04-29	Warnings	Name fallback generic name: LORATADINE

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11523-7200	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-7200	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-7200	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-7200	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-7200	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-7333	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-7333	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-7333	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-7333	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current
11523-7333	Claritin	Loratadine	Bayer HealthCare LLC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85763	SUPPL	2026-04-27
85762	SUPPL	2026-04-27
74417	SUPPL	2023-06-01
74416	SUPPL	2023-06-01
57072	SUPPL	2018-12-31
57042	SUPPL	2018-12-27
55109	SUPPL	2018-08-03
54948	SUPPL	2018-07-23
54744	SUPPL	2018-07-04
54700	SUPPL	2018-06-27
54465	SUPPL	2018-06-06
54439	SUPPL	2018-06-05
53790	SUPPL	2018-04-23
53775	SUPPL	2018-04-23
37943	SUPPL	2015-12-11
6535	SUPPL	2015-12-10
42358	ORIG	2009-08-27
6534	SUPPL	2009-04-10
24229	ORIG	2008-07-17
6533	ORIG	2008-06-19