Application 021312

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLARINEX	DESLORATADINE	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	Yes	Yes
002	CLARINEX	DESLORATADINE	TABLET, ORALLY DISINTEGRATING;ORAL	2.5MG	Yes	No

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
N021312-001	CLARINEX	DESLORATADINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26
N021312-002	CLARINEX	DESLORATADINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021312-001	CLARINEX	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2002-06-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021312-002	CLARINEX	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2005-07-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021312-001	CLARINEX	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021312-002	CLARINEX	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021312-001	CLARINEX	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021312-002	CLARINEX	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021312-001	CLARINEX	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021312-002	CLARINEX	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021312-001	CLARINEX	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021312-002	CLARINEX	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021312-001	CLARINEX	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2002-06-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021312-002	CLARINEX	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2005-07-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021312-001	CLARINEX	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2002-06-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021312-002	CLARINEX	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2005-07-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021312-001	CLARINEX	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2002-06-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021312-002	CLARINEX	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2005-07-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021312-001	CLARINEX	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2002-06-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021312-002	CLARINEX	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2005-07-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021312-001	CLARINEX	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2002-06-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021312-002	CLARINEX	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2005-07-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021312-001	CLARINEX	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021312-002	CLARINEX	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021312-001	CLARINEX	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021312-002	CLARINEX	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021312-001	CLARINEX	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021312-002	CLARINEX	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021312-001	CLARINEX	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021312-002	CLARINEX	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021312-001	CLARINEX	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021312-002	CLARINEX	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021312-001	CLARINEX	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021312-002	CLARINEX	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021312-001	CLARINEX	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021312-002	CLARINEX	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021312-001	CLARINEX	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021312-002	CLARINEX	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021312-001	CLARINEX	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021312-002	CLARINEX	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021312-001	CLARINEX	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2002-06-26	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021312-002	CLARINEX	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2005-07-14	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021312-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021312-002	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021312-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021312-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021312-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021312-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021312-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021312-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021312-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021312-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021312-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021312-002	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021312-001	6100274	2019-07-07		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021312-001	6100274*PED	2020-01-07		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021312-001	7618649	2020-12-19	U-1017	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021312-001	7618649*PED	2021-06-19		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021312-002	6100274	2019-07-07		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021312-002	6100274*PED	2020-01-07		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021312-002	7618649	2020-12-19	U-1017	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021312-002	7618649*PED	2021-06-19		Pediatric extension	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021312-001	7618649*PED	2021-06-19		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021312-002	7618649*PED	2021-06-19		Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021312-001	7618649*PED	2021-06-19		Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021312-002	7618649*PED	2021-06-19		Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021312-001	7618649*PED	2021-06-19		Pediatric extension	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021312-002	7618649*PED	2021-06-19		Pediatric extension	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021312-001	6100274*PED	2020-01-07		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021312-001	7618649	2020-12-19	U-1017	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021312-001	7618649*PED	2021-06-19		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021312-002	6100274*PED	2020-01-07		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021312-002	7618649	2020-12-19	U-1017	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021312-002	7618649*PED	2021-06-19		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021312-001	6100274*PED	2020-01-07		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021312-001	7618649	2020-12-19	U-1017	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021312-001	7618649*PED	2021-06-19		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021312-002	6100274*PED	2020-01-07		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021312-002	7618649	2020-12-19	U-1017	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021312-002	7618649*PED	2021-06-19		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021312-001	6100274	2019-07-07		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021312-001	6100274*PED	2020-01-07		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021312-001	7618649	2020-12-19	U-1017	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021312-001	7618649*PED	2021-06-19		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021312-002	6100274	2019-07-07		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021312-002	6100274*PED	2020-01-07		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021312-002	7618649	2020-12-19	U-1017	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021312-002	7618649*PED	2021-06-19		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021312-001	6100274	2019-07-07		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021312-001	6100274*PED	2020-01-07		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021312-001	7618649	2020-12-19	U-1017	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021312-001	7618649*PED	2021-06-19		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021312-002	6100274	2019-07-07		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021312-002	6100274*PED	2020-01-07		Pediatric extension	`b00525d2431f…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desloratadine	DESLORATADINE	Morepen Bio Inc.	21174c0f-9204-4c75-b6e6-2f9ada5b535d	2026-08-26	Warnings, Adverse reactions	Name fallback generic name: DESLORATADINE
DESLORATADINE	DESLORATADINE	Lupin Pharmaceuticals, Inc.	2a90b899-7746-43dc-ac8a-e754428eb30c	2026-06-30	Warnings, Adverse reactions	Name fallback generic name: DESLORATADINE
DESLORATADINE	DESLORATADINE	Bryant Ranch Prepack	f84c8de3-a7d3-4e8b-bfb6-04259e79450a	2026-06-01	Warnings, Adverse reactions	Name fallback generic name: DESLORATADINE
Desloratadine	DESLORATADINE	Natco Pharma USA LLC	e4db30a5-48e5-4fe3-8793-30b6866f87c1	2026-04-23	Warnings, Adverse reactions	Name fallback generic name: DESLORATADINE
DESLORATADINE	DESLORATADINE	A-S Medication Solutions	a3b61ab9-ec20-4831-b69a-fcd913fce540	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: DESLORATADINE
DESLORATADINE	DESLORATADINE	A-S Medication Solutions	69b9635b-c790-4316-a790-67b0f5512b72	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: DESLORATADINE
Desloratadine	DESLORATADINE	Bryant Ranch Prepack	cf7f838b-4595-4c81-97b9-e1594347e1bd	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: DESLORATADINE
Desloratadine Oral Solution	DESLORATADINE	INA Pharmaceutics, Inc.	41d5e0d4-6188-847b-e063-6294a90a2e2f	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: DESLORATADINE
Desloratadine	DESLORATADINE	Virtus Pharmaceuticals, LLC	0fe374d0-c14b-4102-b568-eb79165fc7ef	2025-07-10	Warnings, Adverse reactions	Name fallback generic name: DESLORATADINE
Clarinex	DESLORATADINE	Organon LLC	c671342e-69a2-4ca5-abc2-8166ed4240d4	2025-05-17	Warnings, Adverse reactions	Name fallback brand name: Clarinex generic name: DESLORATADINE
Desloratadine	DESLORATADINE	Dr. Reddy's Laboratories Limited	e5d1f465-e436-b4fd-d351-07a7b2acb440	2024-02-28	Warnings, Adverse reactions	Name fallback generic name: DESLORATADINE
Desloratadine	DESLORATADINE	A-S Medication Solutions	36307c2b-6b6a-46a9-9fe4-1798fc72e7b8	2023-12-12	Warnings, Adverse reactions	Name fallback generic name: DESLORATADINE
Desloratadine	DESLORATADINE	Bionpharma Inc.	4d094001-b85a-47b3-bc67-a46660384ece	2023-11-27	Warnings, Adverse reactions	Name fallback generic name: DESLORATADINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58021	SUPPL	2019-03-18
58015	SUPPL	2019-03-18
57899	SUPPL	2019-03-05
57887	SUPPL	2019-03-04
36634	SUPPL	2014-04-25
27454	SUPPL	2014-04-24
21592	SUPPL	2011-02-15
5001	SUPPL	2010-12-28
27453	SUPPL	2006-12-28
27452	SUPPL	2006-12-28
5000	SUPPL	2006-12-28
15164	SUPPL	2006-12-26
15165	SUPPL	2005-07-21
4999	SUPPL	2005-07-21
4998	SUPPL	2004-06-01
27451	SUPPL	2004-02-03
42092	ORIG	2003-11-06
27450	ORIG	2002-06-26
15163	ORIG	2002-06-26