Application 021300

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLARINEX	DESLORATADINE	SOLUTION;ORAL	0.5MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021300-001	CLARINEX	DESLORATADINE	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01

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 · 42 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
2026-08-18 06:07:40	2026-07	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021300-001	CLARINEX	0.5MG/ML	SOLUTION / ORAL		RLD	2004-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021300-001	CLARINEX	0.5MG/ML	SOLUTION / ORAL		RLD	2004-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021300-001	CLARINEX	0.5MG/ML	SOLUTION / ORAL		RLD	2004-09-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021300-001	CLARINEX	0.5MG/ML	SOLUTION / ORAL	AA	RLD, RS	2004-09-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021300-001	CLARINEX	0.5MG/ML	SOLUTION / ORAL		RLD	2004-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021300-001	CLARINEX	0.5MG/ML	SOLUTION / ORAL		RLD	2004-09-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021300-001	CLARINEX	0.5MG/ML	SOLUTION / ORAL		RLD	2004-09-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021300-001	CLARINEX	0.5MG/ML	SOLUTION / ORAL		RLD	2004-09-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021300-001	CLARINEX	0.5MG/ML	SOLUTION / ORAL	AA	RLD, RS	2004-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021300-001	CLARINEX	0.5MG/ML	SOLUTION / ORAL	AA	RLD, RS	2004-09-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021300-001	CLARINEX	0.5MG/ML	SOLUTION / ORAL	AA	RLD, RS	2004-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021300-001	CLARINEX	0.5MG/ML	SOLUTION / ORAL	AA	RLD, RS	2004-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021300-001	CLARINEX	0.5MG/ML	SOLUTION / ORAL	AA	RLD, RS	2004-09-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021300-001	CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-09-01	`e64feba35796…`

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	N021300-001	AA	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021300-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021300-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021300-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021300-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021300-001	AA	1	`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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0085-1334	Clarinex	Desloratadine	Merck Sharp & Dohme Corp.	NDA	Current
0085-1334	Clarinex	Desloratadine	Merck Sharp & Dohme Corp.	NDA	Current
0085-1334	Clarinex	Desloratadine	Merck Sharp & Dohme Corp.	NDA	Current
0085-1334	Clarinex	Desloratadine	Merck Sharp & Dohme Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58022	SUPPL	2019-03-18
58014	SUPPL	2019-03-18
57898	SUPPL	2019-03-05
57886	SUPPL	2019-03-04
15133	SUPPL	2014-04-25
4961	SUPPL	2014-04-24
27414	SUPPL	2010-12-28
27413	SUPPL	2006-12-28
27412	SUPPL	2006-12-28
4960	SUPPL	2006-12-28
42089	ORIG	2006-07-25
36608	ORIG	2004-09-03
4959	ORIG	2004-09-03