Application 010104

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	MEPHYTON	PHYTONADIONE	TABLET;ORAL	5MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N010104-003	MEPHYTON	PHYTONADIONE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N010104-003	MEPHYTON	5MG	TABLET / ORAL		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N010104-003	MEPHYTON	5MG	TABLET / ORAL		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N010104-003	MEPHYTON	5MG	TABLET / ORAL		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N010104-003	MEPHYTON	5MG	TABLET / ORAL		RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N010104-003	MEPHYTON	5MG	TABLET / ORAL		RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N010104-003	MEPHYTON	5MG	TABLET / ORAL		RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N010104-003	MEPHYTON	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N010104-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N010104-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N010104-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N010104-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N010104-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N010104-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N010104-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N010104-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N010104-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N010104-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N010104-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N010104-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N010104-003	AB	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N010104-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N010104-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N010104-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N010104-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N010104-003	AB	1	`cb3db0bc1861…`

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
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	HF Acquisition Co LLC, DBA HealthFirst	5686f34b-446a-00ae-e063-6394a90a6029	2026-07-13	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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-1704	Mephyton	phytonadione	Bausch Health US LLC	NDA	Current
0187-1704	Mephyton	phytonadione	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-1704	Mephyton	phytonadione	Bausch Health US LLC	NDA	Current
0187-1704	Mephyton	phytonadione	Bausch Health US LLC	NDA	Current
0187-1704	Mephyton	phytonadione	Bausch Health Americas, Inc.	NDA	Current
0187-1704	Mephyton	phytonadione	Bausch Health US LLC	NDA	Current
21695-168	MEPHYTON	phytonadione	Rebel Distributors Corp	NDA	Current
50090-1753	Mephyton	phytonadione	A-S Medication Solutions	NDA	Current
50090-1753	Mephyton	phytonadione	A-S Medication Solutions	NDA	Current
50090-1753	Mephyton	phytonadione	A-S Medication Solutions	NDA	Current
50268-661	Phytonadione	phytonadione	AvPAK	NDA AUTHORIZED GENERIC	Current
68151-0158	Mephyton	phytonadione	Carilion Materials Management	NDA	Current
68682-170	Phytonadione	phytonadione	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-170	Phytonadione	phytonadione	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-170	Phytonadione	phytonadione	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-170	Phytonadione	phytonadione	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-170	Phytonadione	phytonadione	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-170	Phytonadione	phytonadione	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83117	SUPPL	2025-08-18
68128	SUPPL	2021-07-20
68125	SUPPL	2021-07-20
52765	ORIG	2018-02-28
10736	SUPPL	2012-11-27
11889	SUPPL	2010-01-26
11888	SUPPL	2004-03-02