Application 083722

Type: ANDA
Sponsor: INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHYTONADIONE	PHYTONADIONE	INJECTABLE;INJECTION	1MG/0.5ML	No	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
A083722-001	PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB1	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A083722-001	AB1

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 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
2022-09-29 23:25 UTC	2022-09	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A083722-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB1	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A083722-001	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083722-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083722-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083722-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083722-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083722-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083722-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083722-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083722-001	BP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083722-001	BP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083722-001	BP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083722-001	BP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083722-001	BP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083722-001	BP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083722-001	BP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083722-001	BP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083722-001	BP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083722-001	BP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083722-001	BP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083722-001	BP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083722-001	BP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083722-001	BP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083722-001	BP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083722-001	BP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083722-001	BP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083722-001	BP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083722-001	BP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083722-001	BP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083722-001	BP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083722-001	BP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083722-001	BP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083722-001	BP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083722-001	BP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083722-001	BP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083722-001	BP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083722-001	BP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083722-001	BP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083722-001	BP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083722-001	BP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083722-001	BP	1	`f41ea6bd6efb…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHYTONADIONE	PHYTONADIONE	Henry Schein, Inc.	0d971993-466c-46dd-bdd6-2e300173621e	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083722 application number: ANDA083722 ndc (product): 0404-9935
Phytonadione	PHYTONADIONE	International Medication Systems, Limited	e0b0c8f1-75be-4f25-898a-7b97b608c615	2024-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083722 application number: ANDA083722 ndc (product): 76329-1240

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9935	PHYTONADIONE	phytonadione	Henry Schein, Inc.	ANDA	Current
0404-9935	PHYTONADIONE	phytonadione	Henry Schein, Inc.	ANDA	Current
52584-043	PHYTONADIONE	phytonadione	General Injectables & Vaccines, Inc	ANDA	Current
52584-046	PHYTONADIONE	phytonadione	General Injectables & Vaccines, Inc	ANDA	Current
52584-046	PHYTONADIONE	phytonadione	General Injectables & Vaccines, Inc	ANDA	Current
52584-046	PHYTONADIONE	phytonadione	General Injectables & Vaccines, Inc	ANDA	Current
52584-240	Phytonadione	Phytonadione	General Injectables & Vaccines, Inc	ANDA	Current
76329-1240	Phytonadione	Phytonadione	International Medication Systems, Limited	ANDA	Current
76329-1240	Phytonadione	Phytonadione	International Medication Systems, Limited	ANDA	Current
76329-1240	Phytonadione	Phytonadione	International Medication Systems, Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76936	SUPPL	2023-12-18
76935	SUPPL	2023-12-18
76934	SUPPL	2023-12-18
76933	SUPPL	2023-12-18
76932	SUPPL	2023-12-18
76931	SUPPL	2023-12-18
68759	SUPPL	2021-09-24
68758	SUPPL	2021-09-24