Application 201270

Type: ANDA
Sponsor: LARKEN LABS INC

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
A201270-001	DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB		2017-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201270-001	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 · 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	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201270-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2017-07-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A201270-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201270-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201270-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201270-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201270-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201270-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201270-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201270-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201270-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201270-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201270-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201270-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201270-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201270-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201270-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201270-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201270-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201270-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201270-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201270-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201270-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201270-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201270-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201270-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201270-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201270-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201270-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201270-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201270-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201270-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201270-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201270-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201270-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201270-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201270-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201270-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201270-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201270-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201270-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201270-001	AB	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Advanced Rx Pharmacy of Tennessee, LLC	01cfaa3e-5e30-18fa-e063-6394a90a084e	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201270 application number: ANDA201270
Dexamethasone 1.5 mg	DEXAMETHASONE 1.5 MG	Larken Laboratories, Inc.	7b997c26-e6a3-403c-93fb-b1290cf5dbad	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201270 application number: ANDA201270 ndc (product): 68047-702
Dexamethasone 1.5 mg	DEXAMETHASONE 1.5 MG	Larken Laboratories, Inc.	fcc75691-974e-4a67-b9d7-64dde72b5595	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201270 application number: ANDA201270 ndc (product): 68047-702
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	45fd8030-dbe3-4da4-9d0a-6549cf4f7359	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201270 application number: ANDA201270
Dexamethasone 1.5 mg	DEXAMETHASONE 1.5 MG	Proficient Rx LP	42db0356-3948-444c-bda3-1226b4ca8985	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201270 application number: ANDA201270

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68047-702	Dexamethasone	Dexamethasone 1.5 mg	Larken Laboratories, Inc.	ANDA	Current
68047-702	Dexamethasone	Dexamethasone 1.5 mg	Larken Laboratories, Inc.	ANDA	Current
68047-702	Dexamethasone	Dexamethasone 1.5 mg	Larken Laboratories, Inc.	ANDA	Current
68047-702	Dexamethasone	Dexamethasone 1.5 mg	Larken Laboratories, Inc.	ANDA	Current
68047-702	Dexamethasone	Dexamethasone 1.5 mg	Larken Laboratories, Inc.	ANDA	Current
68047-702	Dexamethasone	Dexamethasone 1.5 mg	Larken Laboratories, Inc.	ANDA	Current
68047-702	Dexamethasone	Dexamethasone 1.5 mg	Larken Laboratories, Inc.	ANDA	Current
68047-702	Dexamethasone	Dexamethasone 1.5 mg	Larken Laboratories, Inc.	ANDA	Current
68047-702	Dexamethasone	Dexamethasone 1.5 mg	Larken Laboratories, Inc.	ANDA	Current
68047-702	Dexamethasone	Dexamethasone 1.5 mg	Larken Laboratories, Inc.	ANDA	Current
68047-702	Dexamethasone	Dexamethasone 1.5 mg	Larken Laboratories, Inc.	ANDA	Current
70362-702	Dxevo	Dexamethasone 1.5 mg	Skylar Laboratories, LLC	ANDA	Current
70362-702	Dxevo	Dexamethasone 1.5 mg	Skylar Laboratories, LLC	ANDA	Current
70362-707	Dxevo	Dexamethasone 1.5 mg	Skylar Laboratories, LLC	ANDA	Current
70569-151	Dxevo	dexamethasone	Phlight Pharma, LLC	ANDA	Current
70569-151	Dxevo	dexamethasone	Phlight Pharma, LLC	ANDA	Current
71905-400	Dexabliss	dexamethasone	Levins Pharmaceuticals, LLC	ANDA	Current
79043-200	ZCORT	dexamethasone	Scite Pharma, LLC	ANDA	Current