Application 211538

Type: ANDA
Sponsor: EAGLE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VASOPRESSIN	VASOPRESSIN	SOLUTION;INTRAVENOUS	20UNITS/ML (20UNITS/ML)	No	No

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

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
A211538-001	VASOPRESSIN	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS			2021-12-15

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS	AP	2021-12-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211538-001	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION / INTRAVENOUS		2021-12-15	`a50c72e98297…`

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	A211538-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211538-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211538-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211538-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211538-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211538-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211538-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211538-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211538-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211538-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211538-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211538-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211538-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211538-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211538-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211538-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211538-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211538-001	AP	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211538-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211538-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211538-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211538-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211538-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211538-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211538-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211538-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211538-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211538-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211538-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211538-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211538-001	AP	1	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211538-001	PC	2022-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211538-001	PC	2022-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211538-001	PC	2022-07-17	`4b0b4de00fa7…`
2023-01-26 05:58 UTC	2023-01	A211538-001	PC	2022-07-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211538-001	PC	2022-07-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211538-001	PC	2022-07-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211538-001	PC	2022-07-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211538-001	PC	2022-07-17	`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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VASOPRESSIN	VASOPRESSIN	HF Acquisition Co LLC, DBA HealthFirst	53372911-5a55-dfac-e063-6394a90ae2f6	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: VASOPRESSIN generic name: VASOPRESSIN
VASOPRESSIN	VASOPRESSIN	HF Acquisition Co LLC, DBA HealthFirst	5232a8bc-d7ae-48a5-e063-6294a90a76ca	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: VASOPRESSIN generic name: VASOPRESSIN
VASOPRESSIN	VASOPRESSIN	HF Acquisition Co LLC, DBA HealthFirst	52324969-4536-2b7c-e063-6394a90a9b4d	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: VASOPRESSIN generic name: VASOPRESSIN
Vasostrict	VASOPRESSIN	Par Health USA, LLC	b1147beb-743e-4c62-8927-91192447f8b8	2026-04-21	Warnings, Adverse reactions	Name fallback generic name: VASOPRESSIN
Vasostrict	VASOPRESSIN	Par Health USA, LLC	b97e5c3e-ca28-4ffa-80af-6c5bdbadaf10	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: VASOPRESSIN
VASOPRESSIN	VASOPRESSIN	ProPharma Distribution	386a8e67-1f18-6513-e063-6294a90a5ffe	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: VASOPRESSIN generic name: VASOPRESSIN
VASOPRESSIN	VASOPRESSIN	Eugia US LLC	eadd82d7-e2cb-4144-9f0c-b340f54c6fa4	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: VASOPRESSIN generic name: VASOPRESSIN
Vasopressin	VASOPRESSIN	Gland Pharma Limited	971f9b1c-6094-4f80-920b-cb5d7e62950a	2025-08-26	Warnings, Adverse reactions	Name fallback brand name: Vasopressin generic name: VASOPRESSIN
VASOPRESSIN	VASOPRESSIN	HF Acquisition Co LLC, DBA HealthFirst	f5f03364-e71c-9bcd-e053-2995a90a8ada	2025-07-11	Warnings, Adverse reactions	Name fallback brand name: VASOPRESSIN generic name: VASOPRESSIN
Vasopressin in 0.9% Sodium Chloride	VASOPRESSIN	Long Grove Pharmaceuticals, LLC	bf4b0b63-0055-40d8-b331-7f9f1ea3214c	2025-06-17	Warnings, Adverse reactions	Name fallback generic name: VASOPRESSIN
vasopressin	VASOPRESSIN	Medical Purchasing Solutions, LLC	3532868c-ac1d-43c8-e063-6394a90a4fd1	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: vasopressin generic name: VASOPRESSIN
Vasopressin	VASOPRESSIN	Civica, Inc.	cce1a220-3178-49ec-b046-f0cb134cf051	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: Vasopressin generic name: VASOPRESSIN
VASOPRESSIN	VASOPRESSIN	Fresenius Kabi USA, LLC	50aef1e8-0a70-466d-93cd-c1b9ed489839	2025-02-27	Warnings, Adverse reactions	Name fallback brand name: VASOPRESSIN generic name: VASOPRESSIN
VASOPRESSIN	VASOPRESSIN	Fresenius Kabi USA, LLC	04e0c406-6b49-4c0b-abc5-9a1a75532485	2025-02-15	Warnings, Adverse reactions	Name fallback brand name: VASOPRESSIN generic name: VASOPRESSIN
Vasopressin	VASOPRESSIN	Sagent Pharmaceuticals	ad3ac280-49da-4816-9097-14517d0c0f85	2024-11-09	Warnings, Adverse reactions	Name fallback brand name: Vasopressin generic name: VASOPRESSIN
Vasopressin	VASOPRESSIN	American Regent, Inc.	0ab267f4-9ec9-44fd-8521-f975074667d9	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: Vasopressin generic name: VASOPRESSIN
vasopressin	VASOPRESSIN	Dr. Reddy's Laboratories, Inc.	caf04d72-679e-daf9-e86f-4867f83b8ac5	2024-07-31	Warnings, Adverse reactions	Name fallback brand name: vasopressin generic name: VASOPRESSIN
vasopressin	VASOPRESSIN	Amneal Pharmaceuticals LLC	d9869345-b02c-4225-a97b-656f14c86dec	2024-07-07	Warnings, Adverse reactions	Name fallback brand name: vasopressin generic name: VASOPRESSIN
VASOPRESSIN	VASOPRESSIN	Eugia US LLC	85e3dc1e-98ae-4c4c-8af9-237375475e08	2023-11-07	Warnings, Adverse reactions	Name fallback brand name: VASOPRESSIN generic name: VASOPRESSIN
VASOPRESSIN	VASOPRESSIN	Medical Purchasing Solutions, LLC	0933a550-03f1-0937-e063-6394a90a1e89	2023-11-02	Warnings, Adverse reactions	Name fallback brand name: VASOPRESSIN generic name: VASOPRESSIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42367-570	VASOPRESSIN	VASOPRESSIN	Eagle Pharmaceuticals, Inc.	ANDA	Current
42367-570	VASOPRESSIN	VASOPRESSIN	Eagle Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69848	ORIG	2022-01-12