Application 078359

Type: ANDA
Sponsor: SUN PHARM INDS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESLORATADINE	DESLORATADINE	TABLET;ORAL	5MG	No	No

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
A078359-001	DESLORATADINE	DESLORATADINE	5MG	TABLET / ORAL			2010-11-16

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078359-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-11-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078359-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-11-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078359-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-11-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078359-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-11-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078359-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-11-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078359-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-11-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078359-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-11-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078359-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2010-11-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078359-001	DESLORATADINE	5MG	TABLET / ORAL		2010-11-16	`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	A078359-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078359-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078359-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078359-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078359-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078359-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078359-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078359-001	AB	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 brand name: DESLORATADINE generic name: DESLORATADINE
DESLORATADINE	DESLORATADINE	Bryant Ranch Prepack	f84c8de3-a7d3-4e8b-bfb6-04259e79450a	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: DESLORATADINE generic name: DESLORATADINE
Desloratadine	DESLORATADINE	Natco Pharma USA LLC	e4db30a5-48e5-4fe3-8793-30b6866f87c1	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Desloratadine generic name: DESLORATADINE
DESLORATADINE	DESLORATADINE	A-S Medication Solutions	a3b61ab9-ec20-4831-b69a-fcd913fce540	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: DESLORATADINE generic name: DESLORATADINE
DESLORATADINE	DESLORATADINE	A-S Medication Solutions	69b9635b-c790-4316-a790-67b0f5512b72	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: DESLORATADINE generic name: DESLORATADINE
Desloratadine	DESLORATADINE	Bryant Ranch Prepack	cf7f838b-4595-4c81-97b9-e1594347e1bd	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Desloratadine 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 brand name: Desloratadine generic name: DESLORATADINE
Clarinex	DESLORATADINE	Organon LLC	c671342e-69a2-4ca5-abc2-8166ed4240d4	2025-05-17	Warnings, Adverse reactions	Name fallback generic name: DESLORATADINE
Desloratadine	DESLORATADINE	Dr. Reddy's Laboratories Limited	e5d1f465-e436-b4fd-d351-07a7b2acb440	2024-02-28	Warnings, Adverse reactions	Name fallback brand name: Desloratadine generic name: DESLORATADINE
Desloratadine	DESLORATADINE	A-S Medication Solutions	36307c2b-6b6a-46a9-9fe4-1798fc72e7b8	2023-12-12	Warnings, Adverse reactions	Name fallback brand name: Desloratadine generic name: DESLORATADINE
Desloratadine	DESLORATADINE	Bionpharma Inc.	4d094001-b85a-47b3-bc67-a46660384ece	2023-11-27	Warnings, Adverse reactions	Name fallback brand name: Desloratadine generic name: DESLORATADINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62756-523	Desloratadine	Desloratadine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-523	Desloratadine	Desloratadine	Sun Pharmaceutical Industries, Inc.	ANDA	Current