Application 205307

Type: ANDA
Sponsor: WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPOFOL	PROPOFOL	INJECTABLE;INJECTION	10MG/ML	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
A205307-001	PROPOFOL	PROPOFOL	10MG/ML	INJECTABLE / INJECTION			2015-12-22

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	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION		2015-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205307-001	PROPOFOL	10MG/ML	INJECTABLE / INJECTION	AB	2015-12-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205307-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205307-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205307-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205307-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205307-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205307-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205307-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205307-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205307-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205307-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205307-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205307-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205307-001	AB	1	`ea99ee380514…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205307-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205307-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205307-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205307-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205307-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205307-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205307-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205307-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205307-001	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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROPOFOL	PROPOFOL	Hospira, Inc.	28d7ba00-f824-4e55-139a-03f509c099db	2026-08-13	Warnings, Adverse reactions	Name fallback brand name: PROPOFOL generic name: PROPOFOL
PROPOFOL	PROPOFOL	Anthea Pharma Private Limited	f23fe3c5-aa37-4ecc-ad76-f13c1a1dabe2	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: PROPOFOL generic name: PROPOFOL
Propofol	PROPOFOL	Civica, Inc	9ba70032-40c2-41c5-9f99-d1f94032d3dc	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Propofol generic name: PROPOFOL
propofol	PROPOFOL	Meitheal Pharmaceuticals Inc.	548d5192-2e5e-4c1b-8f17-940b6e791ae5	2025-12-12	Warnings, Adverse reactions	Name fallback brand name: propofol generic name: PROPOFOL
Propofol	PROPOFOL	Pfizer Laboratories Div Pfizer Inc	3acf8e6c-827d-11e2-9e96-0800200c9a66	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Propofol generic name: PROPOFOL
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	e3105799-a4b6-f3f4-e6e2-b2b29bbdb538	2025-09-11	Warnings, Adverse reactions	Name fallback generic name: PROPOFOL
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	fee3bd4a-ade3-41fa-839a-48e9af69bcf4	2025-09-10	Warnings, Adverse reactions	Name fallback generic name: PROPOFOL
propofol	PROPOFOL	Sagent Pharmaceuticals	fa93f173-7858-4d88-860e-76ab97e65c2f	2025-06-07	Warnings, Adverse reactions	Name fallback brand name: propofol generic name: PROPOFOL
propofol	PROPOFOL	NorthStar Rx LLC	5ec25932-6c21-4cd5-8f60-80761f2e20a6	2025-05-26	Warnings, Adverse reactions	Name fallback brand name: propofol generic name: PROPOFOL
propofol	PROPOFOL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	10272dc1-657d-4798-a34a-b6341b92e560	2025-05-26	Warnings, Adverse reactions	Name fallback brand name: propofol generic name: PROPOFOL
PROPOFOL	PROPOFOL	Amneal Pharmaceuticals Private Limited	6833edd6-ba8a-4b97-a872-ab253c64a903	2025-05-20	Warnings, Adverse reactions	Name fallback brand name: PROPOFOL generic name: PROPOFOL
Propofol	PROPOFOL	Avenacy, LLC	de351d5f-581d-4768-a4af-fbd8e5bce264	2025-04-30	Warnings, Adverse reactions	Name fallback brand name: Propofol generic name: PROPOFOL
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	d1ae9e26-ffd6-43df-bbd6-869cdede6afe	2025-04-21	Warnings, Adverse reactions	Name fallback generic name: PROPOFOL
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	ee0c3437-614d-4631-a061-257f5f60c70b	2025-02-20	Warnings, Adverse reactions	Name fallback generic name: PROPOFOL
PROPOFOL	PROPOFOL	HF Acquisition Co LLC, DBA HealthFirst	99af9e0a-c268-84ca-e053-2a95a90a0a3e	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: PROPOFOL generic name: PROPOFOL
PROPOFOL	PROPOFOL	HF Acquisition Co LLC, DBA HealthFirst	99c8438a-2b3c-796e-e053-2a95a90a0200	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: PROPOFOL generic name: PROPOFOL
Diprivan	PROPOFOL	Fresenius Kabi USA, LLC	5cec3b97-5183-4a9d-accd-21e76c99d3dd	2024-04-18	Warnings, Adverse reactions	Name fallback generic name: PROPOFOL
PROPOFOL	PROPOFOL	HF Acquisition Co LLC, DBA HealthFirst	7b9599e0-5bad-742d-e053-2991aa0aee97	2022-12-09	Warnings, Adverse reactions	Name fallback brand name: PROPOFOL generic name: PROPOFOL
PROPOFOL	PROPOFOL	Hikma Pharmaceuticals USA Inc.	fdb77e13-f5a7-4c4a-9f8e-338b702239c8	2022-11-18	Warnings, Adverse reactions	Name fallback brand name: PROPOFOL generic name: PROPOFOL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9943	PROPOFOL	propofol	Henry Schein, Inc.	ANDA	Current
0591-2136	Propofol	Propofol	Actavis Pharma, Inc.	ANDA	Current
0591-2136	Propofol	Propofol	Actavis Pharma, Inc.	ANDA	Current
0591-2136	Propofol	Propofol	Actavis Pharma, Inc.	ANDA	Current
0591-2136	Propofol	Propofol	Actavis Pharma, Inc.	ANDA	Current
0591-2136	Propofol	Propofol	Actavis Pharma, Inc.	ANDA	Current
50090-4569	Propofol	Propofol	A-S Medication Solutions	ANDA	Current
50090-4569	Propofol	Propofol	A-S Medication Solutions	ANDA	Current
52584-054	Propofol	Propofol	General Injectables and Vaccines, Inc.	ANDA	Current
52584-098	PROPOFOL	propofol	General Injectables & Vaccines, Inc.	ANDA	Current
52584-098	PROPOFOL	propofol	General Injectables & Vaccines, Inc.	ANDA	Current
52584-098	PROPOFOL	propofol	General Injectables & Vaccines, Inc.	ANDA	Current