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| PHYTONADIONE | INJECTABLE;INJECTION | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| PHYTONADIONE | INJECTABLE;INJECTION | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| AQUAMEPHYTON | PHYTONADIONE | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||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| AQUAMEPHYTON | PHYTONADIONE | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N012223-002 | AQUAMEPHYTON | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 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| 2026-07 | N012223-001 | AQUAMEPHYTON | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||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… |
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 |
|---|---|---|---|---|---|---|
| Phytonadione | PHYTONADIONE | Amneal Pharmaceuticals NY LLC | 54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d | 2024-12-09 | Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | American Health Packaging | 88d13044-6ce8-4374-86ff-e8d9eea27829 | 2024-09-24 | Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Northstar Rx LLC. | 5429b58b-ec2b-4a18-95d9-a9d804321192 | 2024-08-05 | Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Zydus Pharmaceuticals USA Inc. | 6c992275-b040-42d0-9eff-570dce4272fe | 2024-08-05 | Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Cipla USA Inc. | 1add4de5-0f9c-453e-9dd5-abb8077b566a | 2024-07-12 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | International Medication Systems, Limited | e0b0c8f1-75be-4f25-898a-7b97b608c615 | 2024-03-12 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| PHYTONADIONE | PHYTONADIONE | Baxter Healthcare Corporation | 98fa1675-8af1-42c5-bbab-8b3632d52a0f | 2023-12-15 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Exelan Pharmaceuticals, Inc. | 63771c95-d4f5-42eb-b591-4df146f18cb0 | 2023-11-01 | Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Cipla USA., Inc. | 7dd1f275-94d3-45d2-a4d0-696ce60a2a9b | 2023-11-01 | Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | ScieGen Pharmaceuticals Inc | c0e38a20-7225-46a5-9730-924cbd08dbee | 2023-08-11 | Adverse reactions | PHYTONADIONE |
| Phytonadione | PHYTONADIONE | Zydus Lifesciences Limited | fa26f747-c64e-4090-a0cf-de3d3d9b004c | 2022-11-01 | PHYTONADIONE | |
| PHYTONADIONE PHYTONADIONE | PHYTONADIONE | Dr.Reddy's Laboratories Inc | 02445c07-7b4b-cd70-54e8-ebefc814f547 | 2019-05-30 | Boxed warning, Warnings, Adverse reactions | PHYTONADIONE |
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 |
|---|---|---|---|---|---|
| 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 |