Application 020118

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUPRANE	DESFLURANE	LIQUID;INHALATION	100%	Yes	Yes

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
N020118-001	SUPRANE	DESFLURANE	100%	LIQUID / INHALATION		RLD, RS	1992-09-18

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020118-001	SUPRANE	100%	LIQUID / INHALATION		RLD, RS	1992-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020118-001	SUPRANE	100%	LIQUID / INHALATION	AN	RLD, RS	1992-09-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020118-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020118-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020118-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020118-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020118-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020118-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020118-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020118-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020118-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020118-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020118-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020118-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020118-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020118-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020118-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020118-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020118-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020118-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020118-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020118-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020118-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020118-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020118-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020118-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020118-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020118-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020118-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020118-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020118-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020118-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020118-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020118-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020118-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020118-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020118-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020118-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020118-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020118-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020118-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020118-001	AN	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Suprane	DESFLURANE	Henry Schein, Inc.	a3e4c8e5-bff0-4a8f-8401-e9866c846ee2	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020118 application number: NDA020118 ndc (product): 0404-9961
SUPRANE	DESFLURANE	Baxter Healthcare Corporation	7f977eb6-c7c4-4dc5-ab3b-07414dbe5da5	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020118 application number: NDA020118 ndc (product): 10019-646
SUPRANE	DESFLURANE	Baxter Healthcare Corporation	3fe3d468-d283-4dd0-a1a7-29291a9b2d0b	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020118 application number: NDA020118 ndc (product): 10019-641
Suprane	DESFLURANE	Baxter Healthcare Corporation	efbb228b-7b38-4176-8bae-826103178c35	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020118 application number: NDA020118 ndc (product): 10019-644

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9961	Suprane	Desflurane	Henry Schein, Inc.	NDA	Current
0404-9961	Suprane	Desflurane	Henry Schein, Inc.	NDA	Current
10019-641	SUPRANE	desflurane	Baxter Healthcare Corporation	NDA	Current
10019-641	SUPRANE	desflurane	Baxter Healthcare Corporation	NDA	Current
10019-641	SUPRANE	desflurane	Baxter Healthcare Corporation	NDA	Current
10019-644	Suprane	DESFLURANE	Baxter Healthcare Corporation	NDA	Current
10019-644	Suprane	DESFLURANE	Baxter Healthcare Corporation	NDA	Current
10019-644	Suprane	DESFLURANE	Baxter Healthcare Corporation	NDA	Current
10019-644	Suprane	DESFLURANE	Baxter Healthcare Corporation	NDA	Current
10019-646	SUPRANE	DESFLURANE	Baxter Healthcare Corporation	NDA	Current
10019-646	SUPRANE	DESFLURANE	Baxter Healthcare Corporation	NDA	Current
10019-646	SUPRANE	DESFLURANE	Baxter Healthcare Corporation	NDA	Current
10019-646	SUPRANE	DESFLURANE	Baxter Healthcare Corporation	NDA	Current
52584-641	Suprane	Desflurane	General Injectables & Vaccines, Inc	NDA	Current
52584-641	Suprane	Desflurane	General Injectables & Vaccines, Inc	NDA	Current
52584-641	Suprane	Desflurane	General Injectables & Vaccines, Inc	NDA	Current
52584-641	Suprane	Desflurane	General Injectables & Vaccines, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72544	SUPPL	2022-11-02
72531	SUPPL	2022-11-02
58002	SUPPL	2019-03-14
58001	SUPPL	2019-03-14
54058	SUPPL	2018-05-08
54057	SUPPL	2018-05-08
48221	SUPPL	2017-05-02
48193	SUPPL	2017-05-02
45849	SUPPL	2016-11-08
45830	SUPPL	2016-11-08
34273	SUPPL	2015-03-02
2029	SUPPL	2015-02-27
2028	SUPPL	2013-09-24
34272	SUPPL	2013-09-23
21173	SUPPL	2010-04-08
12224	SUPPL	2010-04-05
12223	SUPPL	2009-04-23
21172	SUPPL	2009-04-20
21171	SUPPL	2006-12-28
12222	SUPPL	2006-12-26
2027	SUPPL	2006-08-21
34271	SUPPL	2006-08-18
21170	SUPPL	2006-05-16
12221	SUPPL	2006-05-16
51833	SUPPL	1900-01-01
51832	SUPPL	1900-01-01
51831	SUPPL	1900-01-01
51830	SUPPL	1900-01-01