Application 078355

Type: ANDA
Sponsor: BELCHER PHARMS

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
A078355-001	DESLORATADINE	DESLORATADINE	5MG	TABLET / ORAL	AB		2012-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078355-001	AB

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	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078355-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078355-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078355-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078355-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078355-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078355-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078355-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078355-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078355-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078355-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078355-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078355-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078355-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078355-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078355-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078355-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078355-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078355-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078355-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078355-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078355-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078355-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078355-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078355-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078355-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078355-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078355-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078355-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078355-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078355-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078355-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078355-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078355-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078355-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078355-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078355-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078355-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078355-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078355-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078355-001	AB	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desloratadine	DESLORATADINE	Bryant Ranch Prepack	cf7f838b-4595-4c81-97b9-e1594347e1bd	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078355 application number: ANDA078355
Desloratadine	DESLORATADINE	Virtus Pharmaceuticals, LLC	0fe374d0-c14b-4102-b568-eb79165fc7ef	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078355 application number: ANDA078355 ndc (product): 69543-107
Desloratadine	DESLORATADINE	A-S Medication Solutions	36307c2b-6b6a-46a9-9fe4-1798fc72e7b8	2023-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078355 application number: ANDA078355 ndc (product): 50090-3975

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-240	Desloratadine	Desloratadine	AvKARE, Inc.	ANDA	Current
42291-240	Desloratadine	Desloratadine	AvKARE	ANDA	Current
50090-3975	Desloratadine	Desloratadine	A-S Medication Solutions	ANDA	Current
50090-3975	Desloratadine	Desloratadine	A-S Medication Solutions	ANDA	Current
50268-218	Desloratadine	Desloratadine	AvPAK	ANDA	Current
62250-619	Desloratadine	Desloratadine	Belcher Pharmaceuticals,LLC	ANDA	Current
62250-619	Desloratadine	Desloratadine	Belcher Pharmaceuticals,LLC	ANDA	Current
62250-619	Desloratadine	Desloratadine	Belcher Pharmaceuticals,LLC	ANDA	Current
62250-619	Desloratadine	Desloratadine	Belcher Pharmaceuticals,LLC	ANDA	Current
62250-619	Desloratadine	Desloratadine	Belcher Pharmaceuticals,LLC	ANDA	Current
63629-5270	Desloratadine	Desloratadine	Bryant Ranch Prepack	ANDA	Current
69543-107	Desloratadine	Desloratadine	Virtus Pharmaceuticals	ANDA	Current
69543-107	Desloratadine	Desloratadine	Virtus Pharmaceuticals	ANDA	Current
69543-107	Desloratadine	Desloratadine	Virtus Pharmaceuticals	ANDA	Current
69543-107	Desloratadine	Desloratadine	Virtus Pharmaceuticals	ANDA	Current