Application 208609

Type: NDA
Sponsor: AKORN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPHEDRINE SULFATE	EPHEDRINE SULFATE	SOLUTION;INTRAVENOUS	50MG/ML (50MG/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
N208609-001	EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS			2017-03-01

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 · 41 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
2026-02-19 14:30 UTC	2026-02	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-01	`cb3db0bc1861…`

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	N208609-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208609-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208609-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208609-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208609-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208609-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208609-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208609-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208609-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208609-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208609-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208609-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208609-001	AP	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208609-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208609-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208609-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208609-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208609-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208609-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208609-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208609-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208609-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208609-001	AP	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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ephedrine Sulfate	EPHEDRINE SULFATE	Medical Purchasing Solutions, LLC	57b49792-7ea1-c5cc-e063-6394a90a5b2b	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Ephedrine sulfate	EPHEDRINE SULFATE	NorthStar RxLLC	b6fc8311-7853-4666-a1c2-668a04fe2119	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: Ephedrine sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Par Health USA, LLC	38723cb3-dfca-4c81-8c6f-63dd99929191	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Par Health USA, LLC	3e43cc8e-bf4e-44ef-a07d-4336367b9bdb	2026-01-21	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Eugia US LLC	a5862de7-4118-4bda-8075-0b2524e04585	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Walgreen Company	dc0072f9-7111-1af0-e053-2a95a90aed56	2025-09-04	Warnings	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
EPHEDRINE SULFATE	EPHEDRINE SULFATE	REMEDYREPACK INC.	9851cc1c-f267-4e18-b1ad-923fe9cded84	2025-08-12	Warnings, Adverse reactions	Name fallback brand name: EPHEDRINE SULFATE generic name: EPHEDRINE SULFATE
Ephedrine sulfate	EPHEDRINE SULFATE	ProPharma Distribution	3843c820-f54b-5349-e063-6294a90a6b18	2025-07-18	Warnings, Adverse reactions	Name fallback brand name: Ephedrine sulfate generic name: EPHEDRINE SULFATE
ephedrine sulfate	EPHEDRINE SULFATE	Fresenius Kabi USA, LLC	c021fe1b-3ac3-4577-b780-f6a3070908a1	2025-06-17	Warnings, Adverse reactions	Name fallback brand name: ephedrine sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Gland Pharma Limited	523ec357-7fdb-482d-85f1-acb3b25eb764	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	NorthStar Rx LLC	7b29542f-3a32-4113-bb1c-1fbd280046e2	2024-12-30	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Hikma Pharmaceuticals USA Inc.	24787cb1-23e8-4baa-9838-a31a466b8c79	2024-12-21	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Medical Purchasing Solutions, LLC	296b3b1f-a151-fd40-e063-6294a90a4f4e	2024-12-16	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Amneal Pharmaceuticals LLC	765ed48b-b381-418a-9847-068f7f4cc838	2024-12-13	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	CVS Pharmacy, Inc	e338deef-efad-1d82-e053-2995a90a1bf9	2024-12-02	Warnings	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
EPHEDRINE SULFATE	EPHEDRINE SULFATE	Somerset Therapeutics, LLC	86b1c42c-854e-463b-ac99-4aacbbe71fd1	2024-11-14	Warnings, Adverse reactions	Name fallback brand name: EPHEDRINE SULFATE generic name: EPHEDRINE SULFATE
Emerphed PFS	EPHEDRINE SULFATE	Nexus Pharmaceuticals, LLC	14601778-93ac-43ec-b66b-5a942317133f	2024-09-16	Warnings, Adverse reactions	Name fallback generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Caplin Steriles Limited	154ea3d0-d53f-4795-a43b-2f0eae9737f6	2024-07-30	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Hikma Pharmaceuticals USA Inc.	794cb942-04e3-4472-8eb8-92613329e4d5	2024-04-10	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Bronkaid Max	EPHEDRINE SULFATE	Foundation Consumer Healthcare LLC	9a0b792a-caee-41f6-9400-922a5ebd592f	2024-03-14	Warnings	Name fallback generic name: EPHEDRINE SULFATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-415	Ephedrine Sulfate	Ephedrine Sulfate	Akorn	NDA	Current
17478-415	Ephedrine Sulfate	Ephedrine Sulfate	Akorn	NDA	Current
17478-415	Ephedrine Sulfate	Ephedrine Sulfate	Akorn, Inc.	NDA	Current
17478-415	Ephedrine Sulfate	Ephedrine Sulfate	Akorn	NDA	Current
17478-415	Ephedrine Sulfate	Ephedrine Sulfate	Akorn, Inc.	NDA	Current
17478-415	Ephedrine Sulfate	Ephedrine Sulfate	Akorn, Inc.	NDA	Current
17478-415	Ephedrine Sulfate	Ephedrine Sulfate	Akorn, Inc.	NDA	Current
17478-517	Ephedrine Sulfate	Ephedrine Sulfate	Akorn	NDA	Current
17478-517	Ephedrine Sulfate	Ephedrine Sulfate	Akorn	NDA	Current
17478-517	Ephedrine Sulfate	Ephedrine Sulfate	Akorn, Inc.	NDA	Current
17478-517	Ephedrine Sulfate	Ephedrine Sulfate	Akorn	NDA	Current
17478-517	Ephedrine Sulfate	Ephedrine Sulfate	Akorn, Inc.	NDA	Current
17478-517	Ephedrine Sulfate	Ephedrine Sulfate	Akorn, Inc.	NDA	Current
17478-517	Ephedrine Sulfate	Ephedrine Sulfate	Akorn, Inc.	NDA	Current
17478-955	Ephedrine Sulfate	Ephedrine Sulfate	Akorn	NDA	Current
17478-955	Ephedrine Sulfate	Ephedrine Sulfate	Akorn, Inc.	NDA	Current
17478-955	Ephedrine Sulfate	Ephedrine Sulfate	Akorn, Inc.	NDA	Current
17478-955	Ephedrine Sulfate	Ephedrine Sulfate	Akorn	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78772	SUPPL	2024-06-12
78765	SUPPL	2024-06-11
73436	SUPPL	2023-02-09
52882	ORIG	2018-03-09
47462	ORIG	2017-03-03
47386	ORIG	2017-03-02