Application 215106

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	4MG	No	No
002	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	6MG	No	No

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

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
A215106-001	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2021-10-14
A215106-002	DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET / ORAL	AB		2021-10-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A215106-001	AB
A215106-002	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 · 66 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
2026-02-19 14:30 UTC	2026-02	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215106-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2021-10-14	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215106-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2021-10-14	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215106-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215106-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215106-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215106-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215106-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215106-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215106-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215106-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215106-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215106-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215106-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215106-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215106-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215106-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215106-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215106-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215106-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215106-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215106-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215106-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215106-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215106-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215106-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215106-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215106-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215106-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215106-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215106-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215106-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215106-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215106-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215106-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215106-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215106-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215106-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215106-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215106-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A215106-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215106-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215106-002	AB	1	`6a51e52b5d6a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215106-001	CGT	2022-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215106-002	CGT	2022-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215106-001	CGT	2022-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215106-002	CGT	2022-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215106-001	CGT	2022-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215106-002	CGT	2022-04-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215106-001	CGT	2022-04-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215106-002	CGT	2022-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215106-001	CGT	2022-04-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A215106-002	CGT	2022-04-19	`782e0a99824c…`
2023-01-26 05:58 UTC	2023-01	A215106-001	CGT	2022-04-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A215106-002	CGT	2022-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215106-001	CGT	2022-04-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215106-002	CGT	2022-04-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215106-001	CGT	2022-04-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A215106-002	CGT	2022-04-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215106-001	CGT	2022-04-20	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A215106-002	CGT	2022-04-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215106-001	CGT	2022-04-20	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215106-002	CGT	2022-04-19	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dexamethasone	DEXAMETHASONE	Cardinal Health 107, LLC	5622f8d2-1893-441b-8011-fa90c8a63b0b	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215106 application number: ANDA215106
dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	4c619d48-8cf9-4085-8405-c8f066bce19c	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215106 application number: ANDA215106 ndc (product): 68788-8293
dexamethasone	DEXAMETHASONE	Major Pharmaceuticals	64b46398-9b97-45e8-b1ba-1a202d574448	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215106 application number: ANDA215106 ndc (product): 0904-7266
dexamethasone	DEXAMETHASONE	Amneal Pharmaceuticals NY LLC	ac71f888-c83a-46a5-921c-1ebdf6cfadc1	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215106 application number: ANDA215106 ndc (product): 60219-2044 ndc (product): 60219-2043

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7266	dexamethasone	dexamethasone	Major Pharmaceuticals	ANDA	Current
60219-2043	dexamethasone	dexamethasone	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-2043	dexamethasone	dexamethasone	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-2044	dexamethasone	dexamethasone	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-2044	dexamethasone	dexamethasone	Amneal Pharmaceuticals NY LLC	ANDA	Current
68071-2744	dexamethasone	dexamethasone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8223	dexamethasone	dexamethasone	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8293	dexamethasone	dexamethasone	Preferred Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69693	ORIG	2021-12-20