Application 021313

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLARINEX-D 12 HOUR	DESLORATADINE; PSEUDOEPHEDRINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	2.5MG;120MG	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
N021313-001	CLARINEX-D 12 HOUR	DESLORATADINE; PSEUDOEPHEDRINE SULFATE	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2006-02-01

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	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021313-001	6100274	2019-07-07		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	7618649	2020-12-19	U-1017	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	6709676	2021-02-18	U-707	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021313-001	6709676	2021-02-18	U-707	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021313-001	6709676	2021-02-18	U-707	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021313-001	6709676	2021-02-18	U-707	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021313-001	7618649	2020-12-19	U-1017	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021313-001	6709676	2021-02-18	U-707	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021313-001	7618649	2020-12-19	U-1017	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021313-001	6709676	2021-02-18	U-707	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021313-001	6100274	2019-07-07		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	7618649	2020-12-19	U-1017	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	6709676	2021-02-18	U-707	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021313-001	6100274	2019-07-07		Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	7618649	2020-12-19	U-1017	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	6709676	2021-02-18	U-707	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021313-001	6100274	2019-07-07		Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	7618649	2020-12-19	U-1017	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	6709676	2021-02-18	U-707	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`ea99ee380514…`

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
CLARINEX-D 12 HOUR	DESLORATADINE AND PSEUDOEPHEDRINE SULFATE	Organon LLC	1af66b7a-4ab8-40d8-abdd-22d3310228a8	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021313 application number: NDA021313 ndc (product): 78206-120

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
0085-1322	CLARINEX-D 12 HOUR	desloratadine and pseudoephedrine sulfate	Merck Sharp & Dohme Corp.	NDA	Current
0085-1322	CLARINEX-D 12 HOUR	desloratadine and pseudoephedrine sulfate	Merck Sharp & Dohme Corp.	NDA	Current
0085-1322	CLARINEX-D 12 HOUR	desloratadine and pseudoephedrine sulfate	Merck Sharp & Dohme Corp.	NDA	Current
78206-120	CLARINEX-D 12 HOUR	desloratadine and pseudoephedrine sulfate	Organon LLC	NDA	Current
78206-120	CLARINEX-D 12 HOUR	desloratadine and pseudoephedrine sulfate	Organon LLC	NDA	Current
78206-120	CLARINEX-D 12 HOUR	desloratadine and pseudoephedrine sulfate	Organon LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58023	SUPPL	2019-03-18
58017	SUPPL	2019-03-18
53780	SUPPL	2018-04-23
53750	SUPPL	2018-04-20
52515	SUPPL	2018-02-08
52500	SUPPL	2018-02-07
36636	SUPPL	2014-03-10
27456	SUPPL	2014-03-10
36635	SUPPL	2010-01-12
5003	SUPPL	2010-01-05
42093	ORIG	2008-07-09
15167	SUPPL	2007-07-24
5002	SUPPL	2007-07-24
27455	ORIG	2006-02-08
15166	ORIG	2006-02-07