Application 213536
- Type
- NDA
- Sponsor
- SINTETICA, SA
Application Products#
| 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 |
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N213536-001 | REZIPRES | 23.5MG/5ML (4.7MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2021-06-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213536-002 | REZIPRES | 47MG/ML (47MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2021-06-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213536-003 | REZIPRES | 47MG/5ML (9.4MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2021-06-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213536-004 | REZIPRES | 47MG/10ML (4.7MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2023-12-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N213536-001 | REZIPRES | 23.5MG/5ML (4.7MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2021-06-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213536-002 | REZIPRES | 47MG/ML (47MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2021-06-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213536-003 | REZIPRES | 47MG/5ML (9.4MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2021-06-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213536-004 | REZIPRES | 47MG/10ML (4.7MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2023-12-07 | caaa826d4ba7… | |
| 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… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Primatene | EPHEDRINE HYDROCHLORIDE | Foundation Consumer Brands | 2170f081-c03f-47e8-bc63-4052c5e653fa | 2024-11-07 | Warnings | EPHEDRINE HYDROCHLORIDE |
| Ephedrine Hydrochloride | EPHEDRINE HYDROCHLORIDE | Walgreen Company | bcb81dc1-d854-30c0-e053-2a95a90a9fc7 | 2023-12-14 | Warnings | EPHEDRINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| 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 |