Application 216444

Type: ANDA
Sponsor: ALEMBIC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHYTONADIONE	PHYTONADIONE	INJECTABLE;INJECTION	1MG/0.5ML	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
A216444-001	PHYTONADIONE	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB1		2025-09-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216444-001	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.

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	A216444-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB1	2025-09-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216444-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB	2025-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216444-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB	2025-09-08	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216444-001	PHYTONADIONE	1MG/0.5ML	INJECTABLE / INJECTION	AB1	2025-09-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216444-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216444-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216444-001	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216444-001	AB1	1	`a50c72e98297…`

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	Sagent Pharmaceuticals	3d571642-3d3a-41ae-855e-304ae4fff459	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216444 application number: ANDA216444
Phytonadione	PHYTONADIONE	Alembic Pharmaceuticals Limited	6ccb76ab-1549-4a47-a119-8059588ad83d	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216444 application number: ANDA216444
Phytonadione	PHYTONADIONE	Alembic Pharmaceuticals Inc.	b1e53422-c85d-4bb6-af4f-24934cc319b0	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216444 application number: ANDA216444