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 43.

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N010104-003	MEPHYTON	PHYTONADIONE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982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 · 43 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
2026-09-14 22:38:34	2026-08	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
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N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`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UTC	2026-02	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`011fe1cb6892…`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of this ZIP	2025-12	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`31067a03dcf5…`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UTC	2025-08	N010104-003	MEPHYTON	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`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…`

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 2 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
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	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	American Health Packaging	88d13044-6ce8-4374-86ff-e8d9eea27829	2024-09-24	Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Northstar Rx LLC.	5429b58b-ec2b-4a18-95d9-a9d804321192	2024-08-05	Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Zydus Pharmaceuticals USA Inc.	6c992275-b040-42d0-9eff-570dce4272fe	2024-08-05	Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Cipla USA Inc.	1add4de5-0f9c-453e-9dd5-abb8077b566a	2024-07-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	International Medication Systems, Limited	e0b0c8f1-75be-4f25-898a-7b97b608c615	2024-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
PHYTONADIONE	PHYTONADIONE	Baxter Healthcare Corporation	98fa1675-8af1-42c5-bbab-8b3632d52a0f	2023-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Exelan Pharmaceuticals, Inc.	63771c95-d4f5-42eb-b591-4df146f18cb0	2023-11-01	Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Cipla USA., Inc.	7dd1f275-94d3-45d2-a4d0-696ce60a2a9b	2023-11-01	Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	ScieGen Pharmaceuticals Inc	c0e38a20-7225-46a5-9730-924cbd08dbee	2023-08-11	Adverse reactions	Name fallback generic name: PHYTONADIONE
Phytonadione	PHYTONADIONE	Zydus Lifesciences Limited	fa26f747-c64e-4090-a0cf-de3d3d9b004c	2022-11-01		Name fallback generic name: PHYTONADIONE
PHYTONADIONE PHYTONADIONE	PHYTONADIONE	Dr.Reddy's Laboratories Inc	02445c07-7b4b-cd70-54e8-ebefc814f547	2019-05-30	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 · 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