Application 012223
- Type
- NDA
- Sponsor
- TELIGENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AQUAMEPHYTON | PHYTONADIONE | INJECTABLE;INJECTION | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | AQUAMEPHYTON | PHYTONADIONE | INJECTABLE;INJECTION | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N012223-001 | AQUAMEPHYTON | PHYTONADIONE | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N012223-002 | AQUAMEPHYTON | PHYTONADIONE | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N012223-001 | AQUAMEPHYTON | 10MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N012223-001 | AQUAMEPHYTON | 10MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| Vitamin K1 | PHYTONADIONE | Hospira, Inc. | e8808230-2c44-44c6-8cab-8f29b6b34051 | 2026-08-09 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| PHYTONADIONE | PHYTONADIONE | HF Acquisition Co LLC, DBA HealthFirst | 5686f34b-446a-00ae-e063-6394a90a6029 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| PHYTONADIONE | PHYTONADIONE | Sun Pharmaceutical Industries, Inc. | 51c175dd-02f9-68d1-e063-6294a90a4b36 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| PHYTONADIONE | PHYTONADIONE | Amneal Pharmaceuticals Private Limited | ddd351d3-8b9e-482d-9ab8-f367ce1c3cc0 | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| PHYTONADIONE | PHYTONADIONE | Orbicular Pharmaceutical Technologies Private Limited | d954e3d7-a4d5-4798-887d-7af916ff0181 | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Major Pharmaceuticals | 54f23bc8-d8f3-40e8-a93d-3121cc581d54 | 2026-03-16 | Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Sagent Pharmaceuticals | 3d571642-3d3a-41ae-855e-304ae4fff459 | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | GLENMARK PHARMACEUTICALS INC | 60e5abd1-e2fa-4a5e-b25b-3ec6cfdeed14 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Agnitio Inc. | 66ada4f8-c5a9-49f1-848f-e172416892a1 | 2025-12-01 | Adverse reactions | PHYTONADIONE |
| PHYTONADIONE | PHYTONADIONE | Henry Schein, Inc. | 1cf90be3-a744-4db5-999d-a84c67372304 | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| PHYTONADIONE | PHYTONADIONE | Henry Schein, Inc. | 0d971993-466c-46dd-bdd6-2e300173621e | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| phytonadione | PHYTONADIONE | Amneal Pharmaceuticals LLC | 2ce1dd90-11ad-4f74-af16-45b7e59f05da | 2025-10-23 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Alembic Pharmaceuticals Limited | 6ccb76ab-1549-4a47-a119-8059588ad83d | 2025-09-11 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Alembic Pharmaceuticals Inc. | b1e53422-c85d-4bb6-af4f-24934cc319b0 | 2025-09-11 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Coupler LLC | 3e4f86c4-7e89-c864-e063-6394a90a59af | 2025-09-08 | Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Xiromed LLC | a4b394e7-b766-824e-a8bf-f56808de76e1 | 2025-08-21 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Caplin Steriles Limited | 114b1330-6f03-476c-8678-8cd0da189bce | 2025-04-26 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Fresenius Kabi USA, LLC | 02a39690-38e6-42e9-9897-391c2df9e07e | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Cipla USA Inc. | 4bc2de7b-6564-4d77-8a65-6be57b706093 | 2025-01-07 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Gland Pharma Limited | c375bfab-5a4b-40f3-a783-8372158af860 | 2024-12-12 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52565-092 | AquaMEPHYTON | phytonadione | Teligent Pharma, Inc. | NDA | Current |
| 52565-093 | AquaMEPHYTON | PHYTONADIONE | Teligent Pharma, Inc. | NDA | Current |
| 52565-142 | Phytonadione | phytonadione | Teligent Pharma, Inc. | NDA | Current |
| 52565-143 | Phytonadione | PHYTONADIONE | Teligent Pharma, Inc. | NDA | Current |