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 8 of 17 · 339 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equate childrens allergy	LORATADINE	Wal-Mart Stores Inc	5603d5e1-8d95-44b9-aceb-4bc37b162ab1	2025-05-05	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Granules Pharmaceuticals Inc.	d15add22-bc2d-9730-e053-2a95a90acd3f	2025-05-05	Warnings	Name fallback generic name: LORATADINE
Good Sense childrens allergy relief	LORATADINE	L. Perrigo Company	637e309d-9846-45a1-ad11-f67ea85c87b8	2025-05-05	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	Safeway	8a1b3d40-8ec4-7e76-e053-2a95a90a84b1	2025-04-30	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Bi-Mart	1dd299e7-dfdd-459b-bb2b-83e37dd2e63d	2025-04-11	Warnings	Name fallback generic name: LORATADINE
Allergy Relief	LORATADINE	WinCo Foods, LLC	706a59fa-3d15-4e6e-a38e-ad3f2ef46600	2025-04-08	Warnings	Name fallback generic name: LORATADINE
DYE-FREE CHILDRENS LORATADINE	LORATADINE	WAL-MART STORES, INC	ec24da65-23c1-419d-9603-08348d3b9cc7	2025-04-04	Warnings	Name fallback generic name: LORATADINE
Leader Allergy Relief	LORATADINE	Cardinal Health 110, LLC. dba Leader	6f5134c6-ece6-4e35-a0c3-13e0dfa173fa	2025-04-01	Warnings	Name fallback generic name: LORATADINE
up and up allergy relief	LORATADINE	Target Corporation	c4ef0110-89c3-4ded-9a9a-75c0f794f869	2025-03-28	Warnings	Name fallback generic name: LORATADINE
TopCare Allergy Relief 24 hour	LORATADINE	Topco Associates LLC	a500aebf-a020-4da9-afdb-a699077cb8e1	2025-03-28	Warnings	Name fallback generic name: LORATADINE
CounterAct Allergy	LORATADINE	Melaleuca, Inc.	6b5d43ad-a709-4e0b-b91c-36ea0afe7221	2025-03-17	Warnings	Name fallback generic name: LORATADINE
Loratadine ODT	LORATADINE	CVS Pharmacy, Inc.	37443f0d-bda0-4ddc-a2dd-f3daf495cb40	2025-03-17	Warnings	Name fallback generic name: LORATADINE
dg health allergy relief	LORATADINE	Dolgencorp Inc	086a0a53-7092-4dc8-9c5e-0bd78337fedf	2025-03-11	Warnings	Name fallback generic name: LORATADINE
ValuMeds Allergy Relief	LORATADINE	Cabinet Health P.B.C.	7a67f879-9df9-4536-8fd5-4b9aed05fb47	2025-02-28	Warnings	Name fallback generic name: LORATADINE
Loratadine	LORATADINE	Advanced Rx LLC	e96b4671-82dc-4cc6-a8bf-ef6f1efd8a7d	2025-02-25	Warnings	Name fallback generic name: LORATADINE
Loratadine Allergy Relief	LORATADINE	A-S Medication Solutions	0be70365-57ee-4f2e-a30f-bdd5c292992d	2025-02-20	Warnings	Name fallback generic name: LORATADINE
Loratadine Allergy Relief	LORATADINE	A-S Medication Solutions	baaf9c23-0b54-46a2-8aec-13264479a6d7	2025-02-20	Warnings	Name fallback generic name: LORATADINE
allergy relief	LORATADINE	Meijer, Inc.	14f3d1a2-eda7-432a-8fe0-5437b95bdde6	2025-02-14	Warnings	Name fallback generic name: LORATADINE
topcare allergy relief	LORATADINE	Topco Associates LLC	5cc2e469-9080-4beb-804d-187fc335ccdc	2025-02-10	Warnings	Name fallback generic name: LORATADINE
Loratadine antihistamine	LORATADINE	NuCare Pharmaceuticals,Inc.	fc63689e-e449-ca8f-e053-6394a90a54a2	2025-02-05	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