Application 202202

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A202202-001	WARFARIN SODIUM	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2013-03-04
A202202-002	WARFARIN SODIUM	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2013-03-04
A202202-003	WARFARIN SODIUM	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2013-03-04
A202202-004	WARFARIN SODIUM	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2013-03-04
A202202-005	WARFARIN SODIUM	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2013-03-04
A202202-006	WARFARIN SODIUM	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2013-03-04
A202202-007	WARFARIN SODIUM	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2013-03-04
A202202-008	WARFARIN SODIUM	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2013-03-04
A202202-009	WARFARIN SODIUM	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2013-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202202-001	AB
A202202-002	AB
A202202-003	AB
A202202-004	AB
A202202-005	AB
A202202-006	AB
A202202-007	AB
A202202-008	AB
A202202-009	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 · 396 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
2026-10-15 13:18:30	2026-09	A202202-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2013-03-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2013-03-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2013-03-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2013-03-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2013-03-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2013-03-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2013-03-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2013-03-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2013-03-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202202-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2013-03-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202202-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2013-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202202-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-005	WARFARIN SODIUM	4MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-006	WARFARIN SODIUM	5MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-007	WARFARIN SODIUM	6MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-008	WARFARIN SODIUM	7.5MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-009	WARFARIN SODIUM	10MG	TABLET / ORAL	AB	2013-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-001	WARFARIN SODIUM	1MG	TABLET / ORAL	AB	2013-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-002	WARFARIN SODIUM	2MG	TABLET / ORAL	AB	2013-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-003	WARFARIN SODIUM	2.5MG	TABLET / ORAL	AB	2013-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-004	WARFARIN SODIUM	3MG	TABLET / ORAL	AB	2013-03-04	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 396 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A202202-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-005	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-006	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-007	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-008	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202202-009	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202202-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-008	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202202-009	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202202-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-008	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202202-009	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202202-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-008	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202202-009	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202202-004	AB	1	`31067a03dcf5…`

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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Warfarin Sodium	WARFARIN	Bryant Ranch Prepack	3dd9f8ce-75e0-426a-9d22-6af7742a0ca7	2023-12-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202
Warfarin Sodium	WARFARIN	Bryant Ranch Prepack	addaac3d-6fb5-484f-8535-04eb410d2bf0	2023-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202 ndc (product): 71335-1824
Warfarin Sodium	WARFARIN	Bryant Ranch Prepack	c41b7c23-8053-428a-ac1d-8395e714c2f1	2023-04-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202202 application number: ANDA202202 ndc (product): 71335-1786

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 2 of 2 · 126 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-768	Warfarin Sodium	Warfarin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-768	Warfarin Sodium	Warfarin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-768	Warfarin Sodium	Warfarin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-768	Warfarin Sodium	Warfarin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-769	Warfarin Sodium	Warfarin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-769	Warfarin Sodium	Warfarin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-769	Warfarin Sodium	Warfarin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-769	Warfarin Sodium	Warfarin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-769	Warfarin Sodium	Warfarin	Amneal Pharmaceuticals LLC	ANDA	Current
67296-1285	Warfarin Sodium	Warfarin Sodium	RedPharm Drug, Inc.	ANDA	Current
67296-1285	Warfarin Sodium	Warfarin Sodium	RedPharm Drug, Inc.	ANDA	Current
70518-2380	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2380	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2380	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2381	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2381	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2381	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2382	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2382	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2382	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2383	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2383	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2383	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2394	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2394	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2394	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2394	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2395	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2395	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2395	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2717	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2717	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2717	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2717	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2816	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70518-2816	Warfarin Sodium	Warfarin	REMEDYREPACK INC.	ANDA	Current
70934-820	Warfarin Sodium	Warfarin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-821	Warfarin Sodium	Warfarin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-821	Warfarin Sodium	Warfarin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-911	Warfarin Sodium	Warfarin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1595	Warfarin Sodium	Warfarin	Bryant Ranch Prepack	ANDA	Current
71335-1595	Warfarin Sodium	Warfarin	Bryant Ranch Prepack	ANDA	Current
71335-1786	Warfarin Sodium	Warfarin	Bryant Ranch Prepack	ANDA	Current
71335-1786	Warfarin Sodium	Warfarin	Bryant Ranch Prepack	ANDA	Current
71335-1824	Warfarin Sodium	Warfarin	Bryant Ranch Prepack	ANDA	Current
72189-405	Coumadin	WARFARIN SODIUM	Direct_Rx	ANDA	Current