Application 040416

Type: ANDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JANTOVEN	WARFARIN SODIUM	TABLET;ORAL	1MG	No	No
002	JANTOVEN	WARFARIN SODIUM	TABLET;ORAL	2MG	No	No
003	JANTOVEN	WARFARIN SODIUM	TABLET;ORAL	2.5MG	No	No
004	JANTOVEN	WARFARIN SODIUM	TABLET;ORAL	3MG	No	No
005	JANTOVEN	WARFARIN SODIUM	TABLET;ORAL	4MG	No	No
006	JANTOVEN	WARFARIN SODIUM	TABLET;ORAL	5MG	No	No
007	JANTOVEN	WARFARIN SODIUM	TABLET;ORAL	6MG	No	No
008	JANTOVEN	WARFARIN SODIUM	TABLET;ORAL	7.5MG	No	No
009	JANTOVEN	WARFARIN SODIUM	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040416-001	JANTOVEN	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2003-10-02
A040416-002	JANTOVEN	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2003-10-02
A040416-003	JANTOVEN	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2003-10-02
A040416-004	JANTOVEN	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2003-10-02
A040416-005	JANTOVEN	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2003-10-02
A040416-006	JANTOVEN	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2003-10-02
A040416-007	JANTOVEN	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2003-10-02
A040416-008	JANTOVEN	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2003-10-02
A040416-009	JANTOVEN	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2003-10-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 9 matching rows.

Application-product, TE code table
Application-product	TE code
A040416-001	AB
A040416-002	AB
A040416-003	AB
A040416-004	AB
A040416-005	AB
A040416-006	AB
A040416-007	AB
A040416-008	AB
A040416-009	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 10 · 378 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	A040416-001	JANTOVEN	1MG	TABLET / ORAL	AB	2003-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-002	JANTOVEN	2MG	TABLET / ORAL	AB	2003-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-003	JANTOVEN	2.5MG	TABLET / ORAL	AB	2003-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-004	JANTOVEN	3MG	TABLET / ORAL	AB	2003-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-005	JANTOVEN	4MG	TABLET / ORAL	AB	2003-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-006	JANTOVEN	5MG	TABLET / ORAL	AB	2003-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-007	JANTOVEN	6MG	TABLET / ORAL	AB	2003-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-008	JANTOVEN	7.5MG	TABLET / ORAL	AB	2003-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-009	JANTOVEN	10MG	TABLET / ORAL	AB	2003-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040416-001	JANTOVEN	1MG	TABLET / ORAL	AB	2003-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-002	JANTOVEN	2MG	TABLET / ORAL	AB	2003-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-003	JANTOVEN	2.5MG	TABLET / ORAL	AB	2003-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-004	JANTOVEN	3MG	TABLET / ORAL	AB	2003-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-005	JANTOVEN	4MG	TABLET / ORAL	AB	2003-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-006	JANTOVEN	5MG	TABLET / ORAL	AB	2003-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-007	JANTOVEN	6MG	TABLET / ORAL	AB	2003-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-008	JANTOVEN	7.5MG	TABLET / ORAL	AB	2003-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-009	JANTOVEN	10MG	TABLET / ORAL	AB	2003-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-001	JANTOVEN	1MG	TABLET / ORAL	AB	2003-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-002	JANTOVEN	2MG	TABLET / ORAL	AB	2003-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-003	JANTOVEN	2.5MG	TABLET / ORAL	AB	2003-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-004	JANTOVEN	3MG	TABLET / ORAL	AB	2003-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-005	JANTOVEN	4MG	TABLET / ORAL	AB	2003-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-006	JANTOVEN	5MG	TABLET / ORAL	AB	2003-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-007	JANTOVEN	6MG	TABLET / ORAL	AB	2003-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-008	JANTOVEN	7.5MG	TABLET / ORAL	AB	2003-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-009	JANTOVEN	10MG	TABLET / ORAL	AB	2003-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040416-001	JANTOVEN	1MG	TABLET / ORAL	AB	2003-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-002	JANTOVEN	2MG	TABLET / ORAL	AB	2003-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-003	JANTOVEN	2.5MG	TABLET / ORAL	AB	2003-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-004	JANTOVEN	3MG	TABLET / ORAL	AB	2003-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-005	JANTOVEN	4MG	TABLET / ORAL	AB	2003-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-006	JANTOVEN	5MG	TABLET / ORAL	AB	2003-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-007	JANTOVEN	6MG	TABLET / ORAL	AB	2003-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-008	JANTOVEN	7.5MG	TABLET / ORAL	AB	2003-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-009	JANTOVEN	10MG	TABLET / ORAL	AB	2003-10-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040416-001	JANTOVEN	1MG	TABLET / ORAL	AB	2003-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040416-002	JANTOVEN	2MG	TABLET / ORAL	AB	2003-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040416-003	JANTOVEN	2.5MG	TABLET / ORAL	AB	2003-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040416-004	JANTOVEN	3MG	TABLET / ORAL	AB	2003-10-02	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 378 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	A040416-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-008	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040416-009	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040416-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-008	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040416-009	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-008	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040416-009	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040416-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-008	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040416-009	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040416-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040416-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040416-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040416-004	AB	1	`fd3edfee7708…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Jantoven	WARFARIN SODIUM	Upsher-Smith Laboratories, LLC	19a69a72-ac5d-45d5-a94d-a5aaecbe4730	2025-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040416 application number: ANDA040416 ndc (product): 0832-1211 ndc (product): 0832-1217 ndc (product): 0832-1216 ndc (product): 0832-1219 ndc (product): 0832-1218 ndc (product): 0832-1215 ndc (product): 0832-1214 ndc (product): 0832-1213 ndc (product): 0832-1212

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0832-1211	Jantoven	Warfarin Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1212	Jantoven	Warfarin Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1213	Jantoven	Warfarin Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1214	Jantoven	Warfarin Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1215	Jantoven	Warfarin Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1216	Jantoven	Warfarin Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1217	Jantoven	Warfarin Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1218	Jantoven	Warfarin Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1219	Jantoven	Warfarin Sodium	Upsher-Smith Laboratories, LLC	ANDA	Current
55154-5618	Jantoven	Warfarin Sodium	Cardinal Health	ANDA	Current
55154-5619	Jantoven	Warfarin Sodium	Cardinal Health	ANDA	Current
55154-5620	Jantoven	Warfarin Sodium	Cardinal Health	ANDA	Current
55154-5621	Jantoven	Warfarin Sodium	Cardinal Health	ANDA	Current