Application 088237

Type: ANDA
Sponsor: XSPIRE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	1.5MG	No	No

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
A088237-001	DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET / ORAL			1983-04-28

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 · 41 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	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		1983-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088237-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	BP	1983-04-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A088237-001	BP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088237-001	BP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088237-001	BP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088237-001	BP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088237-001	BP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088237-001	BP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088237-001	BP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088237-001	BP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088237-001	BP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088237-001	BP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088237-001	BP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088237-001	BP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088237-001	BP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088237-001	BP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088237-001	BP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088237-001	BP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088237-001	BP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088237-001	BP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088237-001	BP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088237-001	BP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088237-001	BP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088237-001	BP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088237-001	BP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088237-001	BP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088237-001	BP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088237-001	BP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088237-001	BP	1	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEXAMETHASONE	DEXAMETHASONE	Direct Rx	3ff06262-4c6f-4423-99fa-b4d8191ea133	2024-01-09	Warnings, Adverse reactions	Exact identifier ndc (product): 61919-269
TaperDex 6-day	DEXAMETHASONE	Proficient Rx LP	a0d298f3-6ba6-45a5-81bf-82a3ad93d0a9	2020-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088237 application number: ANDA088237 ndc (product): 71205-012
TaperDex 12-day	DEXAMETHASONE	Proficient Rx LP	d66e36d3-f6f8-4fa8-84fb-7717463e37b3	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088237 application number: ANDA088237 ndc (product): 71205-013

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-211	Dexamethasone	dexamethasone	Blenheim Pharmacal, Inc.	ANDA	Current
15014-211	HiDex 6-day	dexamethasone	Gentex Pharma	ANDA	Current
15014-211	HiDex 6-day	dexamethasone	Gentex Pharma, Llc	ANDA	Current
42195-121	TaperDex 6-day	DEXAMETHASONE	Xspire Pharma, Llc	ANDA	Current
42195-121	TaperDex 6-day	DEXAMETHASONE	Xspire Pharma, Llc	ANDA	Current
42195-121	TaperDex 6-day	DEXAMETHASONE	Xspire Pharma, Llc	ANDA	Current
42195-127	TaperDex 7-day	dexamethasone	Xspire Pharma, Llc	ANDA	Current
42195-127	TaperDex 7-day	dexamethasone	Xspire Pharma, Llc	ANDA	Current
42195-127	TaperDex 7-day	dexamethasone	Xspire Pharma, Llc	ANDA	Current
42195-127	TaperDex 7-day	dexamethasone	Xspire Pharma, Llc	ANDA	Current
42195-149	TaperDex 12-day	DEXAMETHASONE	Xspire Pharma, Llc	ANDA	Current
42195-149	TaperDex 12-day	DEXAMETHASONE	Xspire Pharma, Llc	ANDA	Current
42195-149	TaperDex 12-day	DEXAMETHASONE	Xspire Pharma, Llc	ANDA	Current
42195-151	Dexamethasone	DEXAMETHASONE	Xspire Pharma, LLC	ANDA	Current
42195-151	Dexamethasone	DEXAMETHASONE	Xspire Pharma, LLC	ANDA	Current
42195-221	TaperDex 6-day	DEXAMETHASONE	Xspire Pharma, Llc	ANDA	Current
42195-221	TaperDex 6-day	DEXAMETHASONE	Xspire Pharma, Llc	ANDA	Current
42195-221	TaperDex 6-day	DEXAMETHASONE	Xspire Pharma, Llc	ANDA	Current
42195-270	TaperDex 7-day	dexamethasone	Xspire Pharma, Llc	ANDA	Current
42195-270	TaperDex 7-day	dexamethasone	Xspire Pharma, Llc	ANDA	Current
42195-490	TaperDex 12-day	DEXAMETHASONE	Xspire Pharma, Llc	ANDA	Current
42195-490	TaperDex 12-day	DEXAMETHASONE	Xspire Pharma, Llc	ANDA	Current
42195-721	DEXAMETHASONE 6-Day	DEXAMETHASONE	Xspire Pharma, Llc	ANDA	Current
42195-721	DEXAMETHASONE 6-Day	DEXAMETHASONE	Xspire Pharma, Llc	ANDA	Current
49884-086	Dexamethasone	dexamethasone	Par Pharmaceutical Inc.	ANDA	Current
49884-086	Dexamethasone	dexamethasone	Par Pharmaceutical Inc.	ANDA	Current
55700-854	TaperDex 6-day	DEXAMETHASONE	Quality Care Products, LLC	ANDA	Current
61919-269	Dexamethasone	Dexamethasone	Direct Rx	ANDA	Current
61919-269	Dexamethasone	Dexamethasone	Direct Rx	ANDA	Current
61919-269	Dexamethasone	Dexamethasone	Direct Rx	ANDA	Current
61919-269	Dexamethasone	Dexamethasone	Direct Rx	ANDA	Current
71205-012	TaperDex 6-day	DEXAMETHASONE	Proficient Rx LP	ANDA	Current
71205-012	TaperDex 6-day	DEXAMETHASONE	Proficient Rx LP	ANDA	Current
71205-012	TaperDex 6-day	DEXAMETHASONE	Proficient Rx LP	ANDA	Current
71205-013	TaperDex 12-day	DEXAMETHASONE	Proficient Rx LP	ANDA	Current
71205-013	TaperDex 12-day	DEXAMETHASONE	Proficient Rx LP	ANDA	Current