Application 211379

Type: NDA
Sponsor: DEXCEL PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HEMADY	DEXAMETHASONE	TABLET;ORAL	20MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N211379-001	HEMADY	DEXAMETHASONE	20MG	TABLET / ORAL		RLD, RS	2019-10-03

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211379-001	10537585	2037-12-18		Drug product	2020-01-23
N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211379-001	ODE-271	2026-10-03

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211379-001	HEMADY	20MG	TABLET / ORAL	RLD, RS	2019-10-03	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211379-001	10537585	2037-12-18		Drug product	2020-01-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211379-001	11304961	2037-12-18	U-3344	Drug product	2022-04-19	`6a51e52b5d6a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211379-001	ODE-271	2026-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211379-001	ODE-271	2026-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211379-001	ODE-271	2026-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211379-001	ODE-271	2026-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211379-001	ODE-271	2026-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211379-001	ODE-271	2026-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211379-001	ODE-271	2026-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211379-001	ODE-271	2026-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211379-001	ODE-271	2026-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211379-001	ODE-271	2026-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211379-001	ODE-271	2026-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211379-001	ODE-271	2026-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211379-001	ODE-271	2026-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211379-001	ODE-271	2026-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211379-001	ODE-271	2026-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211379-001	ODE-271	2026-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211379-001	ODE-271	2026-10-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211379-001	ODE-271	2026-10-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211379-001	ODE-271	2026-10-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211379-001	ODE-271	2026-10-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211379-001	ODE-271	2026-10-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211379-001	ODE-271	2026-10-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211379-001	ODE-271	2026-10-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211379-001	ODE-271	2026-10-03	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211379-001	ODE-271	2026-10-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211379-001	ODE-271	2026-10-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211379-001	ODE-271	2026-10-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211379-001	ODE-271	2026-10-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211379-001	ODE-271	2026-10-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211379-001	ODE-271	2026-10-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211379-001	ODE-271	2026-10-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211379-001	ODE-271	2026-10-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211379-001	ODE-271	2026-10-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211379-001	ODE-271	2026-10-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211379-001	ODE-271	2026-10-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211379-001	ODE-271	2026-10-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211379-001	ODE-271	2026-10-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211379-001	ODE-271	2026-10-03	`a50c72e98297…`

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
Hemady	DEXAMETHASONE	Edenbridge Pharmaceuticals LLC.	6b9cf32c-6d60-4853-bbfd-2304ffc2c129	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211379 application number: NDA211379

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64239-300	HEMADY	Dexamethasone	Dexcel Pharma Technologies Ltd.	NDA	Current
72893-015	Hemady	Dexamethasone	Acrotech Biopharma LLC	NDA	Current
72893-015	Hemady	Dexamethasone	Acrotech Biopharma LLC	NDA	Current
72893-015	Hemady	Dexamethasone	Acrotech Biopharma LLC	NDA	Current
72893-015	Hemady	Dexamethasone	Acrotech Biopharma LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78727	SUPPL	2024-07-02
78669	SUPPL	2024-06-06
67924	SUPPL	2021-06-28
67917	SUPPL	2021-06-28
61458	ORIG	2019-12-27
60238	ORIG	2019-10-04
60220	ORIG	2019-10-03