Application 020704

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	CLARITIN REDITABS	LORATADINE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	Yes	Yes
003	CLARITIN HIVES RELIEF REDITAB	LORATADINE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020704-002	CLARITIN REDITABS	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD, RS	2002-11-27
N020704-003	CLARITIN HIVES RELIEF REDITAB	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD, RS	2003-11-19

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020704-002	CLARITIN REDITABS	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2002-11-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020704-003	CLARITIN HIVES RELIEF REDITAB	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2003-11-19	`3a93d1ddd44b…`

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.	b681ea25-d00b-4c8a-8054-cc6f983ce337	2025-12-05	Warnings	Exact identifier application applno (NDA): 020704 application number: NDA020704 ndc (product): 11523-4329 ndc (product): 11523-7157

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
11523-4329	Claritin	Loratadine	Bayer Healthcare LLC	NDA	Current
11523-4329	Claritin	Loratadine	Bayer Healthcare LLC.	NDA	Current
11523-4329	Claritin	Loratadine	Bayer Healthcare LLC.	NDA	Current
11523-4329	Claritin	Loratadine	Bayer Healthcare LLC.	NDA	Current
11523-4329	Claritin	Loratadine	Bayer Healthcare LLC.	NDA	Current
11523-7157	Claritin	Loratadine	Bayer Healthcare LLC	NDA	Current
11523-7157	Claritin	Loratadine	Bayer Healthcare LLC.	NDA	Current
11523-7157	Claritin	Loratadine	Bayer Healthcare LLC.	NDA	Current
11523-7157	Claritin	Loratadine	Bayer Healthcare LLC.	NDA	Current
11523-7157	Claritin	Loratadine	Bayer Healthcare LLC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74406	SUPPL	2023-05-30
74374	SUPPL	2023-05-26
67531	SUPPL	2021-05-18
65899	SUPPL	2021-01-13
58629	SUPPL	2019-05-08
58628	SUPPL	2019-05-08
57866	SUPPL	2019-03-01
57856	SUPPL	2019-03-01
55108	SUPPL	2018-08-03
54972	SUPPL	2018-07-25
48465	SUPPL	2017-05-19
48457	SUPPL	2017-05-19
45900	SUPPL	2016-11-16
45837	SUPPL	2016-11-08
13250	SUPPL	2015-12-01
25580	SUPPL	2015-11-27
35180	SUPPL	2014-07-29
3139	SUPPL	2014-07-24
3138	SUPPL	2009-02-03
3137	SUPPL	2008-10-23
20858	SUPPL	2007-03-02
20857	SUPPL	2007-03-02
25579	SUPPL	2006-01-30
20859	SUPPL	2004-12-07
25578	SUPPL	2003-11-25
3136	SUPPL	2002-11-27