Application 078367

Type: ANDA
Sponsor: REDDYS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078367-001	DESLORATADINE	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12
A078367-002	DESLORATADINE	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12

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 · 86 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
2022-03-09 01:35 UTC	2022-03	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-07-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-07-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-07-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-07-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-07-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-07-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-07-12	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-07-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-07-12	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2010-07-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078367-001	DESLORATADINE	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-07-12	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078367-002	DESLORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2010-07-12	`f41ea6bd6efb…`

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	A078367-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078367-002	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A078367-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078367-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078367-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078367-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078367-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078367-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078367-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078367-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078367-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078367-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desloratadine	DESLORATADINE	Dr. Reddy's Laboratories Limited	e5d1f465-e436-b4fd-d351-07a7b2acb440	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078367 application number: ANDA078367 ndc (product): 55111-551 ndc (product): 55111-360

Reported adverse events (FAERS/openFDA)#

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

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
55111-360	Desloratadine	Desloratadine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-360	Desloratadine	Desloratadine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-551	Desloratadine	Desloratadine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-551	Desloratadine	Desloratadine	Dr. Reddy's Laboratories Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31361	ORIG	2010-07-14