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# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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