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 12 of 17 · 339 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHILDRENS LORATADINE	LORATADINE	SAFEWAY	0e0fbbf7-a42e-e101-e063-6294a90a6977	2024-03-15	Warnings	Name fallback generic name: LORATADINE
Wal-itin	LORATADINE	WALGREENS CO.	fb9608d9-b401-40d9-aff3-2bc0dc6e92d8	2024-03-15	Warnings	Name fallback generic name: LORATADINE
DYE-FREE CHILDRENS LORATADINE	LORATADINE	PUBLIX SUPER MARKETS, INC	0b29afdc-3b0f-3958-e063-6394a90a233a	2024-03-15	Warnings	Name fallback generic name: LORATADINE
members mark allergy relief	LORATADINE	Sam's West Inc	95c2b45a-d0e5-467c-aad4-7bbb6c9a5204	2024-03-11	Warnings	Name fallback generic name: LORATADINE
good sense allergy relief	LORATADINE	A-S Medication Solutions	5fda4906-4133-4293-8b39-4ddcf8d39801	2024-02-04	Warnings	Name fallback generic name: LORATADINE
kirkland signature allerclear	LORATADINE	Costco Wholesale Company	2074d52e-8c0a-4e69-bfb1-864ffc07e25f	2024-01-17	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Wal-Mart Stores, Inc	f62c48ab-8dd3-4ed1-a123-d478efe8e839	2024-01-11	Warnings	Name fallback generic name: LORATADINE
DYE-FREE CHILDRENS LORATADINE	LORATADINE	WAL-MART STORES, INC	01d6de60-58b0-453f-a0be-95146ce29ea3	2024-01-11	Warnings	Name fallback generic name: LORATADINE
Childrens Loratadine	LORATADINE	Ohm Laboratories Inc.	c088c998-d823-4bd0-9382-b567221f85a7	2024-01-11	Warnings	Name fallback generic name: LORATADINE
LORATADINE ALLERGY RELIEF 10mg	LORATADINE	YYBA CORP	dcb63e1b-d499-2e84-e053-2995a90af5c7	2024-01-03	Warnings	Name fallback generic name: LORATADINE
ALLERGY RELIEF 10mg	LORATADINE	YYBA CORP	6103cf98-40b1-4d27-8eb7-6f6a06949730	2024-01-03	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Tenshi Kaizen Pvt Ltd	c20b91e0-ef92-6f2f-e053-2a95a90a2a36	2024-01-02	Warnings	Name fallback generic name: LORATADINE
LORATADINE	LORATADINE	CVS PHARMACY, INC	7ed2aec0-4da7-4edc-9998-b96c67c82738	2024-01-02	Warnings	Name fallback generic name: LORATADINE
LORATADINE	LORATADINE	Strides Pharma Inc	16ab6610-ac99-4714-848d-9377c6bca459	2024-01-02	Warnings	Name fallback generic name: LORATADINE
LORATADINE	LORATADINE	Strides Pharma Inc	a54cdbe9-32ec-45ca-948f-9cefbb8e3cbf	2024-01-02	Warnings	Name fallback generic name: LORATADINE
LORATADINE	LORATADINE	Tenshi Kaizen Pvt Ltd	c20b916d-7dd0-1a56-e053-2995a90a3c1b	2024-01-02	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	A-S Medication Solutions	0f6fe391-8709-40f0-8f52-e3357e6ea4f9	2023-12-09	Warnings	Name fallback generic name: LORATADINE
Loratadine Allergy Relief	LORATADINE	OHM LABORATORIES INC.	c35f2cc1-f76d-4824-b0a5-747bca0c3b85	2023-12-08	Warnings	Name fallback generic name: LORATADINE
All Day Allergy Relief	LORATADINE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	7eac9202-bd4c-4550-a257-2b8195a0dbcd	2023-11-29	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	AMERIFOODS TRADING COMPANY	f6ce5292-f698-dd2f-e053-6394a90ad74a	2023-11-02	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