Application 215654

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	INJECTABLE;INJECTION	EQ 4MG PHOSPHATE/ML	No	No
002	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	INJECTABLE;INJECTION	EQ 10MG PHOSPHATE/ML	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
A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP		2021-08-04
A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP		2023-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215654-001	AP
A215654-002	AP

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 · 53 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	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215654-002	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2023-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215654-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2021-08-04	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 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	A215654-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215654-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215654-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215654-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215654-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215654-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215654-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215654-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215654-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215654-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215654-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215654-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215654-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215654-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215654-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215654-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215654-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215654-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215654-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215654-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215654-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215654-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215654-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215654-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215654-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215654-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215654-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215654-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215654-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215654-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215654-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215654-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215654-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215654-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215654-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215654-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215654-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215654-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215654-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215654-001	AP	1	`a72a2bbeb626…`

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 Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC.	41eb3b4a-3386-ebfa-e063-6394a90a4dba	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215654 application number: ANDA215654
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	REMEDYREPACK INC.	11f10a47-1c42-40e4-89d8-bb000fef497c	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215654 application number: ANDA215654
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sagent Pharmaceuticals	4680d517-ed5a-4137-819c-122ee962a464	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215654 application number: ANDA215654
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Gland Pharma Limited	c9d9ab76-6bc6-433d-aad7-8d49064ed745	2024-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215654 application number: ANDA215654 ndc (product): 68083-474 ndc (product): 68083-473

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
68083-473	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Gland Pharma Limited	ANDA	Current
68083-474	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Gland Pharma Limited	ANDA	Current