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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021952-001	CLARITIN	10MG	CAPSULE / ORAL	RLD, RS	2008-06-16	`cb3db0bc1861…`

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 18 · 344 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
allergy relief	LORATADINE	Walgreen Company	41f8fc1d-2d14-48da-a233-23e9c11296d9	2026-07-23	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	Dr. Reddy's Laboratories Inc.	44da36d2-1881-e779-d3a2-13ea828f9240	2026-07-15	Warnings	Name fallback generic name: LORATADINE
Childrens Loratadine	LORATADINE	Sun Pharmaceutical Industries, Inc.	12c8066a-3429-481e-b63a-7ea2b439a170	2026-07-14	Warnings	Name fallback generic name: LORATADINE
Childrens Loratadine Sugar Free	LORATADINE	Sun Pharmaceutical Industries, Inc.	96a76906-58ad-40cd-be27-4ea254e298c5	2026-07-14	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	NuCare Pharmaceuticals, Inc.	569a35be-d653-181c-e063-6294a90a6eb9	2026-07-14	Warnings	Name fallback generic name: LORATADINE
ALLERGY RELIEF	LORATADINE	Meijer, Inc.	190ecdc3-454a-4623-9e4a-09f4ab865084	2026-07-09	Warnings	Name fallback generic name: LORATADINE
dg health allergy relief	LORATADINE	Dolgencorp Inc	dfc4b065-1980-48ec-9c3e-aaa4a42214d3	2026-07-02	Warnings	Name fallback generic name: LORATADINE
CareOne Allergy Relief 24 Hour	LORATADINE	American Sales Company	bbd5424f-fa5b-4955-8542-7011b19400ea	2026-07-01	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	St. Mary's Medical Park Pharmacy	2bc586e4-5297-44cf-e063-6294a90a531d	2026-06-29	Warnings	Name fallback generic name: LORATADINE
childrens allergy relief	LORATADINE	Kroger Company	52934db1-b6fc-43ca-9a8c-66ff47a94745	2026-06-29	Warnings	Name fallback generic name: LORATADINE
All Day Allergy Relief	LORATADINE	WALMART INC. (see also Equate)	db815af2-4193-4fd9-a028-4a9d54325ca8	2026-06-18	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Cardinal Health 107, LLC	64489b01-a4a7-4c6d-ac84-1dfbd1388d84	2026-06-04	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Preferred Pharmaceuticals Inc.	d778c4d2-184a-4dc8-9351-66d81d0618f2	2026-05-28	Warnings	Name fallback generic name: LORATADINE
Good Sense childrens allergy relief	LORATADINE	Preferred Pharmaceuticals Inc.	27bb0a40-35ee-4c19-bd6f-fb054c8a2586	2026-05-28	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Preferred Pharmaceuticals Inc	0a0d700d-bdba-4c90-a947-5d61d40ce4df	2026-05-28	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Preferred Pharmaceuticals Inc.	c6144a33-6b33-4aca-86e5-a3f688b8b317	2026-05-28	Warnings	Name fallback generic name: LORATADINE
allergy relief	LORATADINE	Rite Aid Corporation	5d58ed7a-e40b-417f-a216-5ec6721d361b	2026-05-27	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	Grocery Outlet, Inc	441cfa86-a812-f67f-e063-6394a90a2118	2026-05-21	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	AvPAK	52581dd2-9597-35cb-e063-6294a90a36c7	2026-05-21	Warnings	Name fallback generic name: LORATADINE
Berkley and Jensen Childrens Allergy Relief	LORATADINE	BJWC	7f9b6a94-2be4-4c96-9a7d-8443f911a4cc	2026-05-21	Warnings	Name fallback generic name: LORATADINE

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