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 11 of 17 · 339 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	WALGREEN CO.	c016aad8-df83-99b0-e053-2a95a90a49cf	2024-06-24	Warnings	Name fallback generic name: LORATADINE
Alavert Allergy	LORATADINE	Foundation Consumer Healthcare	1704474a-9b99-de45-e063-6294a90ac59b	2024-06-24	Warnings	Name fallback generic name: LORATADINE
Loratadine ODT	LORATADINE	WALGREEN CO.	7556b959-3ff2-4489-ae06-67ef398c623c	2024-06-18	Warnings	Name fallback generic name: LORATADINE
All Day Allergy Relief	LORATADINE	QUALITY CHOICE (Chain Drug Marketing Association)	a282d209-1015-4570-b9df-7cc0a3753e37	2024-06-17	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Cardinal Health	c96dd1c9-85a0-0792-e053-2a95a90a2264	2024-06-14	Warnings	Name fallback generic name: LORATADINE
childrens allergy relief	LORATADINE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	bc789b82-56ca-4248-b60a-252d9695636a	2024-06-12	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	NuCare Pharmaceuticals,Inc.	6d0c0948-9288-9bb8-e053-2a91aa0abf3a	2024-06-10	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	QUALITY CHOICE (Chain Drug Marketing Association)	c5acd9d7-2f26-41c5-b369-2122251583ec	2024-05-17	Warnings	Name fallback generic name: LORATADINE
All Day Allergy Relief	LORATADINE	QUALITY CHOICE (Chain Drug Marketing Association)	d47a5f1b-fb27-4618-a26e-a5eeabcd87f2	2024-05-16	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	KROGER COMPANY	087ee83f-71aa-3d47-e063-6394a90aed4d	2024-05-08	Warnings	Name fallback generic name: LORATADINE
LORATADINE	LORATADINE	Tenshi Kaizen Pvt Ltd	9c168fbb-6668-4a9d-9c7e-d3441e60eb95	2024-05-07	Warnings	Name fallback generic name: LORATADINE
CHILDRENS LORATADINE ODT	LORATADINE	WALGREEN CO.	cd597728-35fb-4e43-85ea-84af802e1983	2024-05-04	Warnings	Name fallback generic name: LORATADINE
Alavert Allergy	LORATADINE	Foundation Consumer Healthcare	15c3f848-fef6-433b-e063-6394a90abd2b	2024-05-01	Warnings	Name fallback generic name: LORATADINE
Loratadine antihistamine	LORATADINE	Aphena Pharma Solutions - Tennessee, LLC	a2c92766-df4e-4414-9c42-e18bcf9db6b4	2024-04-09	Warnings	Name fallback generic name: LORATADINE
Loratadine Allergy Relief	LORATADINE	Bryant Ranch Prepack	40914eeb-3a85-4691-9fb8-2df72ba1f709	2024-04-05	Warnings	Name fallback generic name: LORATADINE
Loratadine Allergy Relief	LORATADINE	Bryant Ranch Prepack	94642b79-f91a-429f-87f4-dad326d4f3ed	2024-04-03	Warnings	Name fallback generic name: LORATADINE
good sense allergy relief	LORATADINE	A-S Medication Solutions	c288d849-59c9-4883-aac4-bae54acee8ac	2024-03-27	Warnings	Name fallback generic name: LORATADINE
DYE-FREE CHILDRENS LORATADINE	LORATADINE	Ohm Laboratories Inc.	10b0e325-335b-05b6-e063-6394a90a8c2f	2024-03-15	Warnings	Name fallback generic name: LORATADINE
Dye-Free Childrens Loratadine	LORATADINE	Ohm Laboratories Inc.	9e9b2e1c-f565-42ef-9ec4-43bcebc549b7	2024-03-15	Warnings	Name fallback generic name: LORATADINE
Dye-Free Childrens Loratadine	LORATADINE	CVS PHARMACY, INC	0b78fed4-69eb-f66f-e063-6294a90a3b89	2024-03-15	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