Application 077867

Type: ANDA
Sponsor: PIRAMAL CRITICAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOJOURN	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
A077867-001	SOJOURN	SEVOFLURANE	100%	LIQUID / INHALATION	AN		2007-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077867-001	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	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077867-001	SOJOURN	100%	LIQUID / INHALATION	AN	2007-05-02	`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	A077867-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077867-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077867-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077867-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077867-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077867-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077867-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077867-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077867-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077867-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077867-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077867-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077867-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077867-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077867-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077867-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077867-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077867-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077867-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077867-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077867-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077867-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077867-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077867-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077867-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077867-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077867-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077867-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077867-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077867-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077867-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077867-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077867-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077867-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077867-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077867-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077867-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077867-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077867-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077867-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sojourn	SEVOFLURANE	Piramal Critical Care Inc	fedfd1db-7e32-44b2-89e9-7bb00ee6810d	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077867 application number: ANDA077867 ndc (product): 66794-012
Sevoflurane	SEVOFLURANE	Piramal Critical Care Inc	b23e14d7-9e5b-13f4-e053-2a95a90a0cde	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077867 application number: ANDA077867 ndc (product): 66794-022
Sevoflurane	SEVOFLURANE	Bryant Ranch Prepack	06b9f724-6425-4976-93eb-b9ca343ef5cf	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077867 application number: ANDA077867
Sevoflurane	SEVOFLURANE	Piramal Critical Care Inc	3dbab949-6ab7-4040-9c81-314e5bb61d41	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077867 application number: ANDA077867 ndc (product): 66794-015

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66794-012	Sojourn	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-012	Sojourn	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-012	Sojourn	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-012	Sojourn	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-012	Sojourn	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-012	Sojourn	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-012	Sojourn	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-012	Sojourn	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-015	Sevoflurane	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-015	Sevoflurane	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-015	Sevoflurane	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-015	Sevoflurane	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-015	Sevoflurane	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-015	Sevoflurane	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-015	Sevoflurane	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-022	Sevoflurane	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-022	Sevoflurane	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-022	Sevoflurane	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-022	Sevoflurane	Sevoflurane	Piramal Critical Care Inc	ANDA	Current
66794-022	Sevoflurane	Sevoflurane	Piramal Critical Care Inc	ANDA	Current