Application 204485

Type: NDA
Sponsor: PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VASOSTRICT	VASOPRESSIN	SOLUTION;INTRAVENOUS	20UNITS/ML (20UNITS/ML)	Yes	Yes
002	VASOSTRICT	VASOPRESSIN	SOLUTION;INTRAVENOUS	200UNITS/10ML (20UNITS/ML)	Yes	Yes
003	VASOSTRICT	VASOPRESSIN	SOLUTION;INTRAVENOUS	40UNITS/100ML (0.4UNITS/ML)	Yes	Yes
004	VASOSTRICT	VASOPRESSIN	SOLUTION;INTRAVENOUS	60UNITS/100ML (0.6UNITS/ML)	Yes	Yes
005	VASOSTRICT	VASOPRESSIN	SOLUTION;INTRAVENOUS	20UNITS/100ML (0.2UNITS/ML)	Yes	Yes
006	VASOSTRICT	VASOPRESSIN	SOLUTION;INTRAVENOUS	50UNITS/50ML (1UNITS/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204485-001	VASOSTRICT	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-04-17
N204485-002	VASOSTRICT	VASOPRESSIN	200UNITS/10ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2016-12-17
N204485-003	VASOSTRICT	VASOPRESSIN	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15
N204485-004	VASOSTRICT	VASOPRESSIN	60UNITS/100ML (0.6UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2020-04-15
N204485-005	VASOSTRICT	VASOPRESSIN	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-04-21
N204485-006	VASOSTRICT	VASOPRESSIN	50UNITS/50ML (1UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2023-04-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N204485-001	AP
N204485-002	AP
N204485-003	AP
N204485-005	AP

Orange Book patents#

Current patent rows page 1 of 1 · 47 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204485-001	9375478	2035-01-30	U-1857		2016-06-28
N204485-001	9687526	2035-01-30	U-1857		2017-06-27
N204485-001	9744209	2035-01-30	U-1857		2017-08-29
N204485-001	9744239	2035-01-30	U-1857		2017-08-29
N204485-001	9750785	2035-01-30		Drug product	2017-09-05
N204485-002	9375478	2035-01-30	U-1857		2016-06-28
N204485-002	9687526	2035-01-30	U-1857		2017-06-27
N204485-002	9744209	2035-01-30	U-1857		2017-08-29
N204485-002	9744239	2035-01-30	U-1857		2017-08-29
N204485-002	9750785	2035-01-30		Drug product	2017-09-05
N204485-002	9937223	2035-01-30	U-1857		2018-04-10
N204485-003	10010575	2035-01-30	U-1857		2020-05-07
N204485-003	12186362	2035-01-30		Drug product	2025-01-16
N204485-003	9919026	2035-01-30		Drug product	2020-05-07
N204485-003	9925233	2035-01-30	U-1857		2020-05-07
N204485-003	9925234	2035-01-30	U-1857		2020-05-07
N204485-003	9962422	2035-01-30	U-1857		2020-05-07
N204485-003	9968649	2035-01-30	U-1857		2020-05-07
N204485-003	9974827	2035-01-30	U-1857		2020-05-07
N204485-003	9981006	2035-01-30	U-1857		2020-05-07
N204485-004	10010575	2035-01-30	U-1857		2020-05-07
N204485-004	12186362	2035-01-30		Drug product	2025-01-16
N204485-004	9919026	2035-01-30		Drug product	2020-05-07
N204485-004	9925233	2035-01-30	U-1857		2020-05-07
N204485-004	9925234	2035-01-30	U-1857		2020-05-07
N204485-004	9962422	2035-01-30	U-1857		2020-05-07
N204485-004	9968649	2035-01-30	U-1857		2020-05-07
N204485-004	9974827	2035-01-30	U-1857		2020-05-07
N204485-004	9981006	2035-01-30	U-1857		2020-05-07
N204485-005	10010575	2035-01-30	U-1857		2022-01-18
N204485-005	12186362	2035-01-30		Drug product	2025-01-16
N204485-005	9919026	2035-01-30		Drug product	2022-01-18
N204485-005	9925233	2035-01-30	U-1857		2022-01-18
N204485-005	9925234	2035-01-30	U-1857		2022-01-18
N204485-005	9962422	2035-01-30	U-1857		2022-01-18
N204485-005	9968649	2035-01-30	U-1857		2022-01-18
N204485-005	9974827	2035-01-30	U-1857		2022-01-18
N204485-005	9981006	2035-01-30	U-1857		2022-01-18
N204485-006	10010575	2035-01-30	U-1857		2023-05-08
N204485-006	12186362	2035-01-30		Drug product	2025-01-16
N204485-006	9919026	2035-01-30		Drug product	2023-05-08
N204485-006	9925233	2035-01-30	U-1857		2023-05-08
N204485-006	9925234	2035-01-30	U-1857		2023-05-08
N204485-006	9962422	2035-01-30	U-1857		2023-05-08
N204485-006	9968649	2035-01-30	U-1857		2023-05-08
N204485-006	9974827	2035-01-30	U-1857		2023-05-08
N204485-006	9981006	2035-01-30	U-1857		2023-05-08

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 6 · 211 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
2026-02-19 14:30 UTC	2026-02	N204485-001	VASOSTRICT	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-002	VASOSTRICT	200UNITS/10ML (20UNITS/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2016-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-003	VASOSTRICT	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-004	VASOSTRICT	60UNITS/100ML (0.6UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2020-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-005	VASOSTRICT	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-006	VASOSTRICT	50UNITS/50ML (1UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2023-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204485-001	VASOSTRICT	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204485-002	VASOSTRICT	200UNITS/10ML (20UNITS/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2016-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204485-003	VASOSTRICT	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204485-004	VASOSTRICT	60UNITS/100ML (0.6UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2020-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204485-005	VASOSTRICT	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204485-006	VASOSTRICT	50UNITS/50ML (1UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2023-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204485-001	VASOSTRICT	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204485-002	VASOSTRICT	200UNITS/10ML (20UNITS/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2016-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204485-003	VASOSTRICT	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204485-004	VASOSTRICT	60UNITS/100ML (0.6UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2020-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204485-005	VASOSTRICT	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204485-006	VASOSTRICT	50UNITS/50ML (1UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2023-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204485-001	VASOSTRICT	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204485-002	VASOSTRICT	200UNITS/10ML (20UNITS/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2016-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204485-003	VASOSTRICT	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204485-004	VASOSTRICT	60UNITS/100ML (0.6UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2020-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204485-005	VASOSTRICT	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204485-006	VASOSTRICT	50UNITS/50ML (1UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2023-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204485-001	VASOSTRICT	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204485-002	VASOSTRICT	200UNITS/10ML (20UNITS/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2016-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204485-003	VASOSTRICT	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204485-004	VASOSTRICT	60UNITS/100ML (0.6UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2020-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204485-005	VASOSTRICT	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204485-006	VASOSTRICT	50UNITS/50ML (1UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2023-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204485-001	VASOSTRICT	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204485-002	VASOSTRICT	200UNITS/10ML (20UNITS/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2016-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204485-003	VASOSTRICT	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204485-004	VASOSTRICT	60UNITS/100ML (0.6UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2020-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204485-005	VASOSTRICT	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204485-006	VASOSTRICT	50UNITS/50ML (1UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2023-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204485-001	VASOSTRICT	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2014-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204485-002	VASOSTRICT	200UNITS/10ML (20UNITS/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2016-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204485-003	VASOSTRICT	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204485-004	VASOSTRICT	60UNITS/100ML (0.6UNITS/ML)	SOLUTION / INTRAVENOUS		RLD	2020-04-15	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204485-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204485-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204485-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204485-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204485-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204485-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204485-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204485-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204485-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204485-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204485-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204485-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204485-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204485-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204485-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204485-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204485-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204485-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204485-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204485-005	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204485-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204485-005	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204485-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204485-005	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204485-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204485-005	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204485-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204485-005	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204485-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204485-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204485-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N204485-001	AP	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204485-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204485-005	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204485-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N204485-005	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204485-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N204485-005	AP	1	`ea1830bbd6c7…`

Observed Orange Book patent history#

Patent history page 1 of 38 · 1,493 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204485-001	9375478	2035-01-30	U-1857		2016-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-001	9687526	2035-01-30	U-1857		2017-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-001	9744209	2035-01-30	U-1857		2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-001	9744239	2035-01-30	U-1857		2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-001	9750785	2035-01-30		Drug product	2017-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-002	9375478	2035-01-30	U-1857		2016-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-002	9687526	2035-01-30	U-1857		2017-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-002	9744209	2035-01-30	U-1857		2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-002	9744239	2035-01-30	U-1857		2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-002	9750785	2035-01-30		Drug product	2017-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-002	9937223	2035-01-30	U-1857		2018-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-003	10010575	2035-01-30	U-1857		2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-003	12186362	2035-01-30		Drug product	2025-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-003	9919026	2035-01-30		Drug product	2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-003	9925233	2035-01-30	U-1857		2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-003	9925234	2035-01-30	U-1857		2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-003	9962422	2035-01-30	U-1857		2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-003	9968649	2035-01-30	U-1857		2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-003	9974827	2035-01-30	U-1857		2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-003	9981006	2035-01-30	U-1857		2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-004	10010575	2035-01-30	U-1857		2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-004	12186362	2035-01-30		Drug product	2025-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-004	9919026	2035-01-30		Drug product	2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-004	9925233	2035-01-30	U-1857		2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-004	9925234	2035-01-30	U-1857		2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-004	9962422	2035-01-30	U-1857		2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-004	9968649	2035-01-30	U-1857		2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-004	9974827	2035-01-30	U-1857		2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-004	9981006	2035-01-30	U-1857		2020-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-005	10010575	2035-01-30	U-1857		2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-005	12186362	2035-01-30		Drug product	2025-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-005	9919026	2035-01-30		Drug product	2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-005	9925233	2035-01-30	U-1857		2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-005	9925234	2035-01-30	U-1857		2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-005	9962422	2035-01-30	U-1857		2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-005	9968649	2035-01-30	U-1857		2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-005	9974827	2035-01-30	U-1857		2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-005	9981006	2035-01-30	U-1857		2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-006	10010575	2035-01-30	U-1857		2023-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204485-006	12186362	2035-01-30		Drug product	2025-01-16	`011fe1cb6892…`

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
Vasostrict	VASOPRESSIN	Par Health USA, LLC	b1147beb-743e-4c62-8927-91192447f8b8	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204485 application number: NDA204485 ndc (product): 42023-164 ndc (product): 42023-219 ndc (product): 42023-237 ndc (product): 42023-190
Vasostrict	VASOPRESSIN	Par Health USA, LLC	b97e5c3e-ca28-4ffa-80af-6c5bdbadaf10	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204485 application number: NDA204485 ndc (product): 42023-164
Vasostrict	VASOPRESSIN	Medical Purchasin Solutions, LLC	6672a5c9-bcfd-d7fc-e053-2991aa0aef88	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204485 application number: NDA204485 ndc (product): 71872-7014
Vasostrict	VASOPRESSIN	Medical Purchasing Solutions, LLC	d162d386-105d-e916-e053-2995a90a350c	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204485 application number: NDA204485 ndc (product): 71872-7264
VASOPRESSIN	VASOPRESSIN	HF Acquisition Co LLC, DBA HealthFirst	7ae1c8c9-7d75-55a8-e053-2991aa0af05b	2021-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204485 application number: NDA204485 ndc (product): 51662-1314

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42023-164	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-164	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-164	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-164	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-164	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-164	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-164	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-164	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-164	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-164	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-190	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-190	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-190	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-190	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-190	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-190	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-190	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-190	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-190	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-190	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-219	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-219	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-219	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-219	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-219	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-220	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-220	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-220	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-220	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-220	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-237	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
42023-237	Vasostrict	Vasopressin	Par Pharmaceutical, Inc.	NDA	Current
43598-085	Vasopressin	Vasopressin	DR. REDDYS LABORATORIES INC	NDA	Current
51662-1314	VASOPRESSIN	VASOPRESSIN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1314	VASOPRESSIN	VASOPRESSIN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1314	VASOPRESSIN	VASOPRESSIN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1314	VASOPRESSIN	VASOPRESSIN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1607	VASOPRESSIN	VASOPRESSIN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
55150-371	Vasopressin	Vasopressin	AuroMedics Pharma LLC	NDA	Current
71872-7014	Vasostrict	Vasopressin	Medical Purchasin Solutions, LLC	NDA	Current
71872-7014	Vasostrict	Vasopressin	Medical Purchasin Solutions, LLC	NDA	Current
71872-7264	Vasostrict	Vasopressin	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75020	SUPPL	2023-08-09
74970	SUPPL	2023-08-09
74477	SUPPL	2023-04-12
74476	SUPPL	2023-04-12
72830	SUPPL	2022-12-08
72812	SUPPL	2022-12-07
72720	SUPPL	2022-11-27
72709	SUPPL	2022-11-25
72165	SUPPL	2022-09-27
72164	SUPPL	2022-09-27
68151	SUPPL	2021-07-21
68141	SUPPL	2021-07-21
67017	SUPPL	2021-04-09
67014	SUPPL	2021-04-09
66916	SUPPL	2021-03-30
66902	SUPPL	2021-03-29
66785	SUPPL	2021-03-16
64130	SUPPL	2020-07-30
64129	SUPPL	2020-07-30
61979	SUPPL	2020-02-27
61955	SUPPL	2020-02-25
58765	SUPPL	2019-05-17
58727	SUPPL	2019-05-15
48858	SUPPL	2017-06-29
48420	SUPPL	2017-05-17
47991	SUPPL	2017-04-12
47990	SUPPL	2017-04-12
19567	SUPPL	2015-05-07
10348	SUPPL	2015-05-07
24471	ORIG	2015-01-28
22958	ORIG	2015-01-28
19566	SUPPL	2015-01-07
19565	ORIG	2014-09-03
10347	ORIG	2014-04-18