Application 012223

Type: NDA
Sponsor: TELIGENT

Application Products#

Product, Drug, Ingredient table
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PHYTONADIONE	INJECTABLE;INJECTION	10MG/ML *Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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PHYTONADIONE	INJECTABLE;INJECTION	1MG/0.5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
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N012223-001	AQUAMEPHYTON	PHYTONADIONE	10MG/ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N012223-002	AQUAMEPHYTON	PHYTONADIONE	1MG/0.5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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.

Product history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
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UTC	2019-12	N012223-001	AQUAMEPHYTON	10MG/ML *Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`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UTC	2019-12	N012223-002	AQUAMEPHYTON	1MG/0.5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`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UTC	2022-03	N012223-001	AQUAMEPHYTON	10MG/ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`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…`
2021-12-28 21:50 UTC	2021-12	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	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	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	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	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	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	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	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	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	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	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	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	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	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	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	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	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	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	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	`c0c555d07b60…`
2019-12-14 00:12 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	`3f01610625f2…`
2019-12-14 00:12 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	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	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	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	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	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	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	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	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	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`

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.

Matched openFDA labels page 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHYTONADIONE	PHYTONADIONE	HF Acquisition Co LLC, DBA HealthFirst	5686f34b-446a-00ae-e063-6394a90a6029	2026-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
Vitamin K1	PHYTONADIONE	Hospira, Inc.	e8808230-2c44-44c6-8cab-8f29b6b34051	2026-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
PHYTONADIONE	PHYTONADIONE	Sun Pharmaceutical Industries, Inc.	51c175dd-02f9-68d1-e063-6294a90a4b36	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
PHYTONADIONE	PHYTONADIONE	Amneal Pharmaceuticals Private Limited	ddd351d3-8b9e-482d-9ab8-f367ce1c3cc0	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
PHYTONADIONE	PHYTONADIONE	Orbicular Pharmaceutical Technologies Private Limited	d954e3d7-a4d5-4798-887d-7af916ff0181	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Major Pharmaceuticals	54f23bc8-d8f3-40e8-a93d-3121cc581d54	2026-03-16	Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Sagent Pharmaceuticals	3d571642-3d3a-41ae-855e-304ae4fff459	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	GLENMARK PHARMACEUTICALS INC	60e5abd1-e2fa-4a5e-b25b-3ec6cfdeed14	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Agnitio Inc.	66ada4f8-c5a9-49f1-848f-e172416892a1	2025-12-01	Adverse reactions	Name fallback generic name: PHYTONADIONE
PHYTONADIONE	PHYTONADIONE	Henry Schein, Inc.	1cf90be3-a744-4db5-999d-a84c67372304	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
PHYTONADIONE	PHYTONADIONE	Henry Schein, Inc.	0d971993-466c-46dd-bdd6-2e300173621e	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
phytonadione	PHYTONADIONE	Amneal Pharmaceuticals LLC	2ce1dd90-11ad-4f74-af16-45b7e59f05da	2025-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Alembic Pharmaceuticals Limited	6ccb76ab-1549-4a47-a119-8059588ad83d	2025-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Alembic Pharmaceuticals Inc.	b1e53422-c85d-4bb6-af4f-24934cc319b0	2025-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Coupler LLC	3e4f86c4-7e89-c864-e063-6394a90a59af	2025-09-08	Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Xiromed LLC	a4b394e7-b766-824e-a8bf-f56808de76e1	2025-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Caplin Steriles Limited	114b1330-6f03-476c-8678-8cd0da189bce	2025-04-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Fresenius Kabi USA, LLC	02a39690-38e6-42e9-9897-391c2df9e07e	2025-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Cipla USA Inc.	4bc2de7b-6564-4d77-8a65-6be57b706093	2025-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Gland Pharma Limited	c375bfab-5a4b-40f3-a783-8372158af860	2024-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57280	SUPPL	2019-01-18
52998	SUPPL	2018-03-15
52879	SUPPL	2018-03-08
48562	SUPPL	2017-05-30
48555	SUPPL	2017-05-30
33078	SUPPL	2015-09-03
313	SUPPL	2003-06-08
312	SUPPL	2003-03-10
11994	SUPPL	2001-05-18