Application 078650

Type: ANDA
Sponsor: HALOCARBON PRODS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEVOFLURANE	SEVOFLURANE	LIQUID;INHALATION	100%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078650-001	SEVOFLURANE	SEVOFLURANE	100%	LIQUID / INHALATION	AN		2007-11-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078650-001	AN

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 · 42 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
2026-08-18 06:07:40	2026-07	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078650-001	SEVOFLURANE	100%	LIQUID / INHALATION	AN	2007-11-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078650-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078650-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078650-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078650-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078650-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078650-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078650-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078650-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078650-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078650-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078650-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078650-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078650-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078650-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078650-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078650-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078650-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078650-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078650-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078650-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078650-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078650-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078650-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078650-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078650-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078650-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078650-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078650-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078650-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078650-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078650-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078650-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078650-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078650-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078650-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078650-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078650-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078650-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078650-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078650-001	AN	1	`e64feba35796…`

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
Sevoflurane	SEVOFLURANE	Halocarbon Life Sciences, LLC	bdde7502-6218-401c-9a4f-dd3bc3a80f72	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078650 application number: ANDA078650 ndc (product): 12164-005

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
12164-005	Sevoflurane	sevoflurane	Halocarbon Life Sciences, LLC	ANDA	Current
12164-005	Sevoflurane	sevoflurane	Halocarbon Life Sciences, LLC	ANDA	Current
12164-005	Sevoflurane	sevoflurane	Halocarbon Products Corp.	ANDA	Current
72163-005	Sevoflurane Bostonbio	Sevoflurane	Boston Biopharma	ANDA	Current
72163-005	Sevoflurane Bostonbio	Sevoflurane	Boston Biopharma	ANDA	Current
72163-005	Sevoflurane Bostonbio	Sevoflurane	Boston Biopharma	ANDA	Current