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 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208609-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS		2017-03-01	`caaa826d4ba7…`
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…`

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 2 of 2 · 36 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	08f5ec19-7b53-681b-e063-6294a90acc86	2023-10-30	Warnings, Adverse reactions	Name fallback brand name: Ephedrine sulfate generic name: EPHEDRINE SULFATE
Ephedrine sulfate	EPHEDRINE SULFATE	Dr. Reddy's Laboratories, Inc.	1d1c41c1-8f5f-ee76-c890-4f1f2a3b2e96	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: Ephedrine sulfate generic name: EPHEDRINE SULFATE
EPHEDRINE SULFATE	EPHEDRINE SULFATE	Par Health USA, LLC	a247857e-ba7b-4a37-b132-4ba9b0d1c4d1	2023-05-31	Warnings, Adverse reactions	Name fallback brand name: EPHEDRINE SULFATE generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Medical Purchasing Solutions, LLC	d163ff39-d1a4-b61f-e053-2995a90ab6d5	2023-05-02	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Medical Purchasing Solutions, LLC	c8e8ec0e-988b-85a1-e053-2a95a90a2268	2023-04-25	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Xiromed, LLC	8302176c-d443-97f1-1a49-12b9a204121a	2023-04-11	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Civica, Inc.	8f6c6588-77b6-40c7-a897-52e881854d7f	2023-03-31	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Sagent Pharmaceuticals	614e6649-a0e1-4428-855b-363abdb126d8	2023-03-03	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
ephedrine sulfate	EPHEDRINE SULFATE	Baxter Healthcare Corporation	552c341b-4892-4dc7-8b9f-cb6be914b0d1	2023-01-20	Warnings, Adverse reactions	Name fallback brand name: ephedrine sulfate generic name: EPHEDRINE SULFATE
Emerphed	EPHEDRINE SULFATE	Nexus Pharamaceuticals Inc.	e1323592-dc57-4c9d-b84d-442648a7b114	2022-09-30	Warnings, Adverse reactions	Name fallback generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Fresenius Kabi USA, LLC	5ecd9746-25c7-4bd4-9503-eb97e7db5aa5	2022-08-24	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
EPHEDRINE SULFATE	EPHEDRINE SULFATE	Par Health USA, LLC	2c203482-8a04-40fc-93d2-74b30dec7742	2022-04-30	Warnings, Adverse reactions	Name fallback brand name: EPHEDRINE SULFATE generic name: EPHEDRINE SULFATE
Ephedrine sulfate	EPHEDRINE SULFATE	Lifestar Pharma LLC	49fc67d1-3b30-456b-951c-ca7f703432ab	2022-04-22	Warnings, Adverse reactions	Name fallback brand name: Ephedrine sulfate generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Gland Pharma Limited	4a66e6c1-6d01-46fa-a2da-566fbf6e11a4	2022-03-04	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE
Akovaz	EPHEDRINE SULFATE	Exela Pharma Sciences, LLC	e92f3eda-33eb-4b34-9e8b-db8d32a5dbd9	2020-11-27	Warnings, Adverse reactions	Name fallback generic name: EPHEDRINE SULFATE
Ephedrine Sulfate	EPHEDRINE SULFATE	Sandoz Inc	c8af7bb5-41da-4f8c-8acd-f489892a0d72	2020-05-20	Warnings, Adverse reactions	Name fallback brand name: Ephedrine Sulfate generic name: EPHEDRINE SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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