Application 208943

Type: NDA
Sponsor: PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CORPHEDRA	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
N208943-001	CORPHEDRA	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP		2017-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208943-001	AP

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	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208943-001	CORPHEDRA	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-01-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N208943-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208943-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208943-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208943-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208943-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208943-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208943-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208943-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208943-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208943-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208943-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208943-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208943-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208943-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208943-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208943-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208943-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208943-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208943-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208943-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208943-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208943-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208943-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208943-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208943-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208943-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208943-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208943-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208943-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208943-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208943-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208943-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208943-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208943-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208943-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208943-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208943-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208943-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208943-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208943-001	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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ephedrine Sulfate	EPHEDRINE SULFATE	Par Health USA, LLC	38723cb3-dfca-4c81-8c6f-63dd99929191	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208943 application number: NDA208943 ndc (product): 42023-216
Ephedrine Sulfate	EPHEDRINE SULFATE	Par Health USA, LLC	3e43cc8e-bf4e-44ef-a07d-4336367b9bdb	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208943 application number: NDA208943 ndc (product): 42023-216
EPHEDRINE SULFATE	EPHEDRINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	78c1daef-6e1e-5f2c-e053-2a91aa0a0dba	2024-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208943 application number: NDA208943 ndc (product): 51662-1325

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42023-196	Corphedra	Ephedrine Sulfate	Par Pharmaceutical, Inc.	NDA	Current
42023-196	Corphedra	Ephedrine Sulfate	Par Pharmaceutical, Inc.	NDA	Current
42023-196	Corphedra	Ephedrine Sulfate	Par Pharmaceutical, Inc.	NDA	Current
42023-216	Ephedrine Sulfate	Ephedrine Sulfate	Par Pharmaceutical, Inc.	NDA	Current
42023-216	Ephedrine Sulfate	Ephedrine Sulfate	Par Pharmaceutical, Inc.	NDA	Current
42023-233	Corphedra	ephedrine sulfate	Par Pharmaceutical, Inc.	NDA	Current
51662-1325	EPHEDRINE SULFATE	EPHEDRINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1325	EPHEDRINE SULFATE	EPHEDRINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1325	EPHEDRINE SULFATE	EPHEDRINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1325	EPHEDRINE SULFATE	EPHEDRINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53817	ORIG	2018-04-25
47058	ORIG	2017-01-31
47036	ORIG	2017-01-27