Application 204300
- Type
- NDA
- Sponsor
- AVADEL LEGACY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 10MG/ML (10MG/ML) | Yes | Yes |
| 002 | VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 50MG/5ML (10MG/ML) | Yes | Yes |
| 003 | VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 100MG/10ML (10MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N204300-001 | VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 | |
| N204300-002 | VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 | |
| N204300-003 | VAZCULEP | PHENYLEPHRINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 |
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 | N204300-001 | VAZCULEP | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204300-002 | VAZCULEP | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204300-003 | VAZCULEP | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N204300-001 | VAZCULEP | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204300-002 | VAZCULEP | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204300-003 | VAZCULEP | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204300-001 | VAZCULEP | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204300-002 | VAZCULEP | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204300-003 | VAZCULEP | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204300-001 | VAZCULEP | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204300-002 | VAZCULEP | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204300-003 | VAZCULEP | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2014-06-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204300-001 | VAZCULEP | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204300-002 | VAZCULEP | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204300-003 | VAZCULEP | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204300-001 | VAZCULEP | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204300-002 | VAZCULEP | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204300-003 | VAZCULEP | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204300-001 | VAZCULEP | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204300-002 | VAZCULEP | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204300-003 | VAZCULEP | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204300-001 | VAZCULEP | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204300-002 | VAZCULEP | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204300-003 | VAZCULEP | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204300-001 | VAZCULEP | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204300-002 | VAZCULEP | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204300-003 | VAZCULEP | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204300-001 | VAZCULEP | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204300-002 | VAZCULEP | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204300-003 | VAZCULEP | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204300-001 | VAZCULEP | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204300-002 | VAZCULEP | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204300-003 | VAZCULEP | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N204300-001 | VAZCULEP | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N204300-002 | VAZCULEP | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N204300-003 | VAZCULEP | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204300-001 | VAZCULEP | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204300-002 | VAZCULEP | 50MG/5ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204300-003 | VAZCULEP | 100MG/10ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204300-001 | VAZCULEP | 10MG/ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP1 | RLD, RS | 2014-06-27 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | N204300-001 | AP1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204300-002 | AP1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204300-003 | AP1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204300-001 | AP1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204300-002 | AP1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204300-003 | AP1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204300-001 | AP1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204300-002 | AP1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204300-003 | AP1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204300-001 | AP1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204300-002 | AP1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204300-003 | AP1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204300-001 | AP1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204300-002 | AP1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204300-003 | AP1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204300-001 | AP1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204300-002 | AP1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204300-003 | AP1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204300-001 | AP1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204300-002 | AP1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204300-003 | AP1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N204300-001 | AP1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N204300-002 | AP1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N204300-003 | AP1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204300-001 | AP1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204300-002 | AP1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204300-003 | AP1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204300-001 | AP1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204300-002 | AP1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204300-003 | AP1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204300-001 | AP1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204300-002 | AP1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204300-003 | AP1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N204300-001 | AP1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N204300-002 | AP1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N204300-003 | AP1 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204300-001 | AP1 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204300-002 | AP1 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204300-003 | AP1 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N204300-001 | AP1 | 1 | 5d02ea3f76ae… |
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 |
|---|---|---|---|---|---|---|
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | c7026b15-1228-4acb-beed-4474fcdbb972 | 2022-10-11 | Warnings, Adverse reactions | PHENYLEPHRINE HYDROCHLORIDE |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Sandoz Inc | 6feb2da2-05ef-47bb-9d8d-01b81ad69059 | 2022-03-01 | Warnings, Adverse reactions | PHENYLEPHRINE HYDROCHLORIDE |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Xellia Pharmaceuticals USA LLC | abd39d9c-fcda-4d01-8a58-1d54ba7ac651 | 2021-11-16 | Warnings, Adverse reactions | PHENYLEPHRINE HYDROCHLORIDE |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | Somerset Therapeutics, LLC | 90a3853e-49d6-4536-be72-82cc875bcf74 | 2021-09-01 | Warnings, Adverse reactions | PHENYLEPHRINE HYDROCHLORIDE |
| phenylephrine hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Gland Pharma Limited | 6486d284-5189-4000-aa7d-67150e84a7b2 | 2021-04-14 | Warnings, Adverse reactions | PHENYLEPHRINE HYDROCHLORIDE |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | Meitheal Pharmaceuticals Inc. | 943638b7-527b-4724-a6b7-2018862396d4 | 2020-11-30 | Warnings, Adverse reactions | PHENYLEPHRINE HYDROCHLORIDE |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Sagent Pharmaceuticals | b3ff0d1d-6f3f-4e3c-9407-6f3bf3a61e7d | 2020-07-10 | Warnings, Adverse reactions | PHENYLEPHRINE HYDROCHLORIDE |
| CVS Health Four Actions Nasal Decongestant | PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy,Inc. | c91b5525-6afb-4fea-afcb-9c4578075975 | 2016-09-22 | Warnings | PHENYLEPHRINE 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 |
|---|---|---|---|---|---|
| 51754-4000 | Vazculep | Phenylephrine Hydrochloride | Exela Phrama Sciences, LLC | NDA | Current |
| 51754-4010 | Vazculep | Phenylephrine Hydrochloride | Exela Phrama Sciences, LLC | NDA | Current |
| 51754-4020 | Vazculep | Phenylephrine Hydrochloride | Exela Phrama Sciences, LLC | NDA | Current |
| 68001-331 | Vazculep | Phenylephrine Hydrochloride | BluePoint Laboratories | NDA | Current |
| 71872-7042 | Vazculep | Phenylephrine Hydrochloride | Medical Purchasing Solutions, LLC | NDA | Current |
| 71872-7042 | Vazculep | Phenylephrine Hydrochloride | Medical Purchasing Solutions, LLC | NDA | Current |
| 76014-004 | Vazculep | Phenylephrine Hydrochloride | Avadel Legacy Pharmaceuticals, LLC | NDA | Current |
| 76014-004 | Vazculep | Phenylephrine Hydrochloride | Avadel Legacy Pharmaceuticals, LLC | NDA | Current |
| 76014-004 | Vazculep | Phenylephrine Hydrochloride | Avadel Legacy Pharmaceuticals, LLC | NDA | Current |
| 76014-004 | Vazculep | Phenylephrine Hydrochloride | Avadel Legacy Pharmaceuticals, LLC | NDA | Current |