Application 019627

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIPRIVAN	PROPOFOL	INJECTABLE;INJECTION	10MG/ML	No	No
002	DIPRIVAN	PROPOFOL	INJECTABLE;INJECTION	10MG/ML	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019627-001	DIPRIVAN	PROPOFOL	10MG/ML	INJECTABLE / INJECTION			1989-10-02
N019627-002	DIPRIVAN	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019627-002	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 3 · 84 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	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019627-001	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION			1989-10-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019627-002	DIPRIVAN	10MG/ML	INJECTABLE / INJECTION	AB	RLD, RS	1996-06-11	`bb7c543d1eb4…`

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	N019627-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019627-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019627-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019627-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019627-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019627-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019627-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019627-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019627-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019627-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019627-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019627-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019627-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019627-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019627-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019627-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019627-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019627-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019627-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019627-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019627-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019627-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019627-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019627-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019627-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019627-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019627-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019627-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019627-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019627-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019627-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019627-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019627-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019627-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019627-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019627-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019627-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019627-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019627-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019627-002	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019627-002	8476010*PED	2025-06-01	Pediatric extension		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019627-002	8476010	2024-12-01	Drug substance, Drug product	2013-07-02	`8869cabd3fbd…`

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
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	e3105799-a4b6-f3f4-e6e2-b2b29bbdb538	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019627 application number: NDA019627 ndc (product): 63323-269
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	fee3bd4a-ade3-41fa-839a-48e9af69bcf4	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019627 application number: NDA019627 ndc (product): 63323-269
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	d1ae9e26-ffd6-43df-bbd6-869cdede6afe	2025-04-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019627 application number: NDA019627 ndc (product): 63323-269
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	ee0c3437-614d-4631-a061-257f5f60c70b	2025-02-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019627 application number: NDA019627 ndc (product): 63323-269
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	5cec3b97-5183-4a9d-accd-21e76c99d3dd	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019627 application number: NDA019627 ndc (product): 65219-800

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49836-024	Anesthesia S/I-60	Propofol, Sterile Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-024	Anesthesia S/I-60	Propofol, Sterile Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-024	Anesthesia S/I-60	Propofol, Sterile Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-025	Anesthesia S/I-40	Propofol, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-025	Anesthesia S/I-40	Propofol, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-025	Anesthesia S/I-40	Propofol, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
52584-269	Diprivan	Diprivan	General Injectables & Vaccines, Inc	NDA	Current
63323-269	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
63323-269	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
63323-269	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
63323-269	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
63323-269	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
63323-269	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
63323-269	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
63323-269	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
63323-269	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
63323-269	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
63323-269	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
63323-269	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
63323-269	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
65219-800	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
65219-800	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current
65219-800	Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85080	SUPPL	2026-02-19
85079	SUPPL	2026-02-19
71993	SUPPL	2022-09-01
71986	SUPPL	2022-09-01
68284	SUPPL	2021-08-04
67461	SUPPL	2021-05-12
48220	SUPPL	2017-05-02
48192	SUPPL	2017-05-02
33816	SUPPL	2014-06-10
11571	SUPPL	2014-01-28
40941	SUPPL	2013-09-24
17492	SUPPL	2013-09-17
40940	SUPPL	2009-01-12
20269	SUPPL	2009-01-12
11570	SUPPL	2008-04-23
17491	SUPPL	2008-04-16
20268	SUPPL	2007-07-09
20267	SUPPL	2007-07-09
23549	ORIG	2007-06-18
11569	SUPPL	2007-02-21
17490	SUPPL	2007-02-12
11568	SUPPL	2001-02-23
1425	SUPPL	2001-02-23