Application 021993

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLARITIN REDITABS	LORATADINE	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	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
N021993-001	CLARITIN REDITABS	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD, RS	2006-12-12

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	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021993-001	CLARITIN REDITABS	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2006-12-12	`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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Claritin Reditabs	LORATADINE	Bayer HealthCare LLC	7dc04b48-f053-4e4b-a493-9e8286d2a791	2025-12-05	Warnings	Exact identifier application applno (NDA): 021993 application number: NDA021993 ndc (product): 11523-7202

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11523-7202	Claritin	Loratadine	Bayer HealthCare LLC	NDA	Current
11523-7202	Claritin	Loratadine	Bayer HealthCare LLC	NDA	Current
11523-7202	Claritin	Loratadine	Bayer HealthCare LLC	NDA	Current
11523-7202	Claritin	Loratadine	Bayer HealthCare LLC	NDA	Current
11523-7202	Claritin	Loratadine	Bayer HealthCare LLC	NDA	Current
11523-7202	Claritin	Loratadine	Bayer HealthCare LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74407	SUPPL	2023-05-30
74377	SUPPL	2023-05-26
57867	SUPPL	2019-03-01
57857	SUPPL	2019-03-01
55107	SUPPL	2018-08-03
54971	SUPPL	2018-07-25
38030	SUPPL	2015-12-01
29007	SUPPL	2015-11-27
38029	SUPPL	2014-07-29
6625	SUPPL	2014-07-24
6624	SUPPL	2008-10-23
42372	ORIG	2008-10-03
38028	ORIG	2006-12-14
29006	ORIG	2006-12-14