Home Applications 213407 Application 213407
Type NDA
Sponsor NEXUS PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EMERPHED EPHEDRINE SULFATE INJECTABLE;INJECTION 50MG/10ML Yes No 002 EMERPHED EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 25MG/5ML (5MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213407-001 EMERPHED EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2020-04-17 N213407-002 EMERPHED EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N213407-001 AP1
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213407-001 11090278 2040-05-16 U-3183 2021-08-13 N213407-001 11241400 2040-05-16 U-3183 2022-02-22 N213407-001 11464752 2040-05-16 Drug product 2022-10-17 N213407-001 11478436 2040-05-16 U-3183 2022-11-18 N213407-001 11571398 2040-05-16 U-3183 2023-03-02 N213407-002 11464752 2040-05-16 Drug product 2023-03-02 N213407-002 11571398 2040-05-16 U-3183 2023-03-02
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 · 60 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 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2020-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2020-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP1 RLD, RS 2020-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213407-002 EMERPHED 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213407-001 EMERPHED 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-04-17 1c564ffb4f44…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 5 · 180 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 N213407-001 11090278 2040-05-16 U-3183 2021-08-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213407-001 11241400 2040-05-16 U-3183 2022-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213407-001 11464752 2040-05-16 Drug product 2022-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213407-001 11478436 2040-05-16 U-3183 2022-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213407-001 11571398 2040-05-16 U-3183 2023-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213407-002 11464752 2040-05-16 Drug product 2023-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213407-002 11571398 2040-05-16 U-3183 2023-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-001 11090278 2040-05-16 U-3183 2021-08-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-001 11241400 2040-05-16 U-3183 2022-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-001 11464752 2040-05-16 Drug product 2022-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-001 11478436 2040-05-16 U-3183 2022-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-001 11571398 2040-05-16 U-3183 2023-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-002 11464752 2040-05-16 Drug product 2023-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213407-002 11571398 2040-05-16 U-3183 2023-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213407-001 11090278 2040-05-16 U-3183 2021-08-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213407-001 11241400 2040-05-16 U-3183 2022-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213407-001 11464752 2040-05-16 Drug product 2022-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213407-001 11478436 2040-05-16 U-3183 2022-11-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213407-001 11571398 2040-05-16 U-3183 2023-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213407-002 11464752 2040-05-16 Drug product 2023-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213407-002 11571398 2040-05-16 U-3183 2023-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-001 11090278 2040-05-16 U-3183 2021-08-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-001 11241400 2040-05-16 U-3183 2022-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-001 11464752 2040-05-16 Drug product 2022-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-001 11478436 2040-05-16 U-3183 2022-11-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-001 11571398 2040-05-16 U-3183 2023-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-002 11464752 2040-05-16 Drug product 2023-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213407-002 11571398 2040-05-16 U-3183 2023-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-001 11090278 2040-05-16 U-3183 2021-08-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-001 11241400 2040-05-16 U-3183 2022-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-001 11464752 2040-05-16 Drug product 2022-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-001 11478436 2040-05-16 U-3183 2022-11-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-001 11571398 2040-05-16 U-3183 2023-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-002 11464752 2040-05-16 Drug product 2023-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213407-002 11571398 2040-05-16 U-3183 2023-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213407-001 11090278 2040-05-16 U-3183 2021-08-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213407-001 11241400 2040-05-16 U-3183 2022-02-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213407-001 11464752 2040-05-16 Drug product 2022-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213407-001 11478436 2040-05-16 U-3183 2022-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213407-001 11571398 2040-05-16 U-3183 2023-03-02 03ed91905a0d…
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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 14789-250 Emerphed Ephedrine Sulfate Nexus Pharamaceuticals Inc. NDA Current 14789-250 Emerphed Ephedrine Sulfate Nexus Pharamaceuticals Inc. NDA Current 14789-250 Emerphed Ephedrine Sulfate Nexus Pharmaceuticals Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 79429 SUPPL 2024-08-16 79426 SUPPL 2024-08-16 73998 SUPPL 2023-04-14 73997 SUPPL 2023-04-14 63977 ORIG 2020-07-21 62607 ORIG 2020-04-20 62606 ORIG 2020-04-20