Home Applications 213536 Application 213536
Type NDA
Sponsor SINTETICA, SA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 REZIPRES EPHEDRINE HYDROCHLORIDE INJECTABLE;INJECTION 4.7MG/ML No No 002 REZIPRES EPHEDRINE HYDROCHLORIDE INJECTABLE;INJECTION 9.4MG/ML No No 003 REZIPRES EPHEDRINE HYDROCHLORIDE INJECTABLE;INJECTION 47MG/ML No No 004 REZIPRES EPHEDRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 47MG/10ML (4.7MG/ML) Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213536-001 REZIPRES EPHEDRINE HYDROCHLORIDE 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 N213536-002 REZIPRES EPHEDRINE HYDROCHLORIDE 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 N213536-003 REZIPRES EPHEDRINE HYDROCHLORIDE 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 N213536-004 REZIPRES EPHEDRINE HYDROCHLORIDE 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2023-12-07
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 · 116 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 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2023-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2023-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2023-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213536-001 REZIPRES 23.5MG/5ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213536-002 REZIPRES 47MG/ML (47MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213536-003 REZIPRES 47MG/5ML (9.4MG/ML) SOLUTION / INTRAVENOUS RLD 2021-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213536-004 REZIPRES 47MG/10ML (4.7MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-12-07 d06236e962d9…
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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 39822-1410 REZIPRES Ephedrine hydrochloride XGen Pharmaceuticals DJB, Inc. NDA Current 71863-210 REZIPRES Ephedrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current 71863-210 REZIPRES Ephedrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current 71863-211 REZIPRES Ephedrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current 71863-211 REZIPRES Ephedrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current 71863-212 REZIPRES Ephedrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current 71863-212 REZIPRES Ephedrine hydrochloride Eton Pharmaceuticals, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 69327 ORIG 2021-11-16 67823 ORIG 2021-06-15 67821 ORIG 2021-06-15