Home Applications 215875 Application 215875
Type NDA
Sponsor PH HEALTH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ADRENALIN EPINEPHRINE SOLUTION;INTRAVENOUS 2MG/250ML (8MCG/ML) Yes Yes 002 ADRENALIN EPINEPHRINE SOLUTION;INTRAVENOUS 4MG/250ML (16MCG/ML) Yes Yes 003 ADRENALIN EPINEPHRINE SOLUTION;INTRAVENOUS 5MG/250ML (20MCG/ML) Yes Yes 004 ADRENALIN EPINEPHRINE SOLUTION;INTRAVENOUS 8MG/250ML (32MCG/ML) Yes Yes 005 ADRENALIN EPINEPHRINE SOLUTION;INTRAVENOUS 10MG/250ML (40MCG/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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215875-001 ADRENALIN EPINEPHRINE 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 N215875-002 ADRENALIN EPINEPHRINE 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 N215875-003 ADRENALIN EPINEPHRINE 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 N215875-004 ADRENALIN EPINEPHRINE 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 N215875-005 ADRENALIN EPINEPHRINE 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21
Orange Book patents# Current patent rows page 1 of 1 · 20 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215875-001 10653646 2039-03-21 Drug product 2023-05-10 N215875-001 11083698 2039-03-21 U-3567 2023-05-10 N215875-001 11207280 2039-03-21 Drug product 2023-05-10 N215875-001 12133837 2039-03-21 Drug product 2024-11-06 N215875-002 10653646 2039-03-21 Drug product 2023-05-10 N215875-002 11083698 2039-03-21 U-3567 2023-05-10 N215875-002 11207280 2039-03-21 Drug product 2023-05-10 N215875-002 12133837 2039-03-21 Drug product 2024-11-06 N215875-003 10653646 2039-03-21 Drug product 2023-05-10 N215875-003 11083698 2039-03-21 U-3567 2023-05-10 N215875-003 11207280 2039-03-21 Drug product 2023-05-10 N215875-003 12133837 2039-03-21 Drug product 2024-11-06 N215875-004 10653646 2039-03-21 Drug product 2023-05-10 N215875-004 11083698 2039-03-21 U-3567 2023-05-10 N215875-004 11207280 2039-03-21 Drug product 2023-05-10 N215875-004 12133837 2039-03-21 Drug product 2024-11-06 N215875-005 10653646 2039-03-21 Drug product 2023-05-10 N215875-005 11083698 2039-03-21 U-3567 2023-05-10 N215875-005 11207280 2039-03-21 Drug product 2023-05-10 N215875-005 12133837 2039-03-21 Drug product 2024-11-06
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 3 · 110 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 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 5bbf6a4d5a75…
Observed Orange Book patent history# Patent history page 1 of 10 · 375 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 N215875-001 10653646 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-001 11083698 2039-03-21 U-3567 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-001 11207280 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-001 12133837 2039-03-21 Drug product 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-002 10653646 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-002 11083698 2039-03-21 U-3567 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-002 11207280 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-002 12133837 2039-03-21 Drug product 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-003 10653646 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-003 11083698 2039-03-21 U-3567 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-003 11207280 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-003 12133837 2039-03-21 Drug product 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-004 10653646 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-004 11083698 2039-03-21 U-3567 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-004 11207280 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-004 12133837 2039-03-21 Drug product 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-005 10653646 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-005 11083698 2039-03-21 U-3567 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-005 11207280 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-005 12133837 2039-03-21 Drug product 2024-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-001 10653646 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-001 11083698 2039-03-21 U-3567 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-001 11207280 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-001 12133837 2039-03-21 Drug product 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-002 10653646 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-002 11083698 2039-03-21 U-3567 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-002 11207280 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-002 12133837 2039-03-21 Drug product 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-003 10653646 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-003 11083698 2039-03-21 U-3567 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-003 11207280 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-003 12133837 2039-03-21 Drug product 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-004 10653646 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-004 11083698 2039-03-21 U-3567 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-004 11207280 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-004 12133837 2039-03-21 Drug product 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-005 10653646 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-005 11083698 2039-03-21 U-3567 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-005 11207280 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-005 12133837 2039-03-21 Drug product 2024-11-06 31067a03dcf5…
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 · 1 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 77042 ORIG 2023-12-19 75918 SUPPL 2023-10-24 74051 ORIG 2023-04-24 74040 ORIG 2023-04-24