Application 209373

Type: ANDA
Sponsor: AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHYTONADIONE	PHYTONADIONE	TABLET;ORAL	5MG	No	No

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
A209373-001	PHYTONADIONE	PHYTONADIONE	5MG	TABLET / ORAL	AB		2018-05-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A209373-001	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209373-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	2018-05-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209373-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209373-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209373-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209373-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209373-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209373-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209373-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209373-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209373-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209373-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209373-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209373-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209373-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209373-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209373-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209373-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209373-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209373-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209373-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209373-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209373-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209373-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209373-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209373-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209373-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209373-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209373-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209373-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209373-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209373-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209373-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209373-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209373-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209373-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209373-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209373-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209373-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209373-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209373-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209373-001	AB	1	`e64feba35796…`

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phytonadione	PHYTONADIONE	Major Pharmaceuticals	54f23bc8-d8f3-40e8-a93d-3121cc581d54	2026-03-16	Adverse reactions	Exact identifier application applno (ANDA): 209373 application number: ANDA209373 ndc (product): 0904-6882
Phytonadione	PHYTONADIONE	Amneal Pharmaceuticals NY LLC	54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d	2024-12-09	Adverse reactions	Exact identifier application applno (ANDA): 209373 application number: ANDA209373 ndc (product): 69238-1051
Phytonadione	PHYTONADIONE	American Health Packaging	88d13044-6ce8-4374-86ff-e8d9eea27829	2024-09-24	Adverse reactions	Exact identifier application applno (ANDA): 209373 application number: ANDA209373 ndc (product): 60687-381

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6882	Phytonadione	Phytonadione	Major Pharmaceuticals	ANDA	Current
0904-6882	Phytonadione	Phytonadione	Major Pharmaceuticals	ANDA	Current
0904-6882	Phytonadione	Phytonadione	Major Pharmaceuticals	ANDA	Current
60687-381	Phytonadione	Phytonadione	American Health Packaging	ANDA	Current
60687-381	Phytonadione	Phytonadione	American Health Packaging	ANDA	Current
60687-381	Phytonadione	Phytonadione	American Health Packaging	ANDA	Current
69238-1051	Phytonadione	Phytonadione	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1051	Phytonadione	Phytonadione	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1051	Phytonadione	Phytonadione	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1051	Phytonadione	Phytonadione	Amneal Pharmaceuticals NY LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54450	ORIG	2018-06-05