Application 210189

Type: ANDA
Sponsor: ZYDUS

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
A210189-001	PHYTONADIONE	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210189-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB	RS	2019-02-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210189-001	PHYTONADIONE	5MG	TABLET / ORAL	AB		2019-02-20	`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	A210189-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210189-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210189-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210189-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210189-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210189-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210189-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210189-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210189-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210189-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210189-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210189-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210189-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210189-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210189-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210189-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210189-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210189-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210189-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210189-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210189-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210189-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210189-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210189-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210189-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210189-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210189-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210189-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210189-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210189-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210189-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210189-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210189-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210189-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210189-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210189-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210189-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210189-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210189-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210189-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phytonadione	PHYTONADIONE	Coupler LLC	3e4f86c4-7e89-c864-e063-6394a90a59af	2025-09-08	Adverse reactions	Exact identifier application applno (ANDA): 210189 application number: ANDA210189
Phytonadione	PHYTONADIONE	Northstar Rx LLC.	5429b58b-ec2b-4a18-95d9-a9d804321192	2024-08-05	Adverse reactions	Exact identifier application applno (ANDA): 210189 application number: ANDA210189 ndc (product): 16714-973
Phytonadione	PHYTONADIONE	Zydus Pharmaceuticals USA Inc.	6c992275-b040-42d0-9eff-570dce4272fe	2024-08-05	Adverse reactions	Exact identifier application applno (ANDA): 210189 application number: ANDA210189 ndc (product): 70710-1014
Phytonadione	PHYTONADIONE	Zydus Lifesciences Limited	fa26f747-c64e-4090-a0cf-de3d3d9b004c	2022-11-01		Exact identifier application applno (ANDA): 210189 application number: ANDA210189 ndc (product): 70771-1318

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
16714-973	Phytonadione	Phytonadione	Northstar Rx LLC.	ANDA	Current
16714-973	Phytonadione	Phytonadione	Northstar Rx LLC.	ANDA	Current
16714-973	Phytonadione	Phytonadione	Northstar Rx LLC.	ANDA	Current
60687-600	Phytonadione	Phytonadione	American Health Packaging	ANDA	Current
70710-1014	Phytonadione	Phytonadione	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1014	Phytonadione	Phytonadione	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1014	Phytonadione	Phytonadione	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1318	Phytonadione	Phytonadione	Zydus Lifesciences Limited	ANDA	Current
70771-1318	Phytonadione	Phytonadione	Cadila Healthcare Limited	ANDA	Current
70771-1318	Phytonadione	Phytonadione	Cadila Healthcare Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68768	ORIG	2021-09-24