Application 218107

Type: ANDA
Sponsor: BIOCON PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIVAROXABAN	RIVAROXABAN	TABLET;ORAL	2.5MG	No	No
002	RIVAROXABAN	RIVAROXABAN	TABLET;ORAL	10MG	No	No
003	RIVAROXABAN	RIVAROXABAN	TABLET;ORAL	15MG	No	No
004	RIVAROXABAN	RIVAROXABAN	TABLET;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A218107-001	RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET / ORAL	BX	2025-05-14
A218107-002	RIVAROXABAN	RIVAROXABAN	10MG	TABLET / ORAL	BX	2025-05-14
A218107-003	RIVAROXABAN	RIVAROXABAN	15MG	TABLET / ORAL	BX	2025-05-14
A218107-004	RIVAROXABAN	RIVAROXABAN	20MG	TABLET / ORAL	BX	2025-05-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A218107-001	BX
A218107-002	BX
A218107-003	BX
A218107-004	BX

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
2026-09-14 22:38:34	2026-08	A218107-001	RIVAROXABAN	2.5MG	TABLET / ORAL	BX	2025-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218107-002	RIVAROXABAN	10MG	TABLET / ORAL	BX	2025-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218107-003	RIVAROXABAN	15MG	TABLET / ORAL	BX	2025-05-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218107-004	RIVAROXABAN	20MG	TABLET / ORAL	BX	2025-05-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218107-001	RIVAROXABAN	2.5MG	TABLET / ORAL	BX	2025-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218107-002	RIVAROXABAN	10MG	TABLET / ORAL	BX	2025-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218107-003	RIVAROXABAN	15MG	TABLET / ORAL	BX	2025-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218107-004	RIVAROXABAN	20MG	TABLET / ORAL	BX	2025-05-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218107-001	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218107-002	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218107-003	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218107-004	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218107-001	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218107-002	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218107-003	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218107-004	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218107-001	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218107-002	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218107-003	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218107-004	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-14	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218107-001	RIVAROXABAN	2.5MG	TABLET / ORAL	BX	2025-05-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218107-002	RIVAROXABAN	10MG	TABLET / ORAL	BX	2025-05-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218107-003	RIVAROXABAN	15MG	TABLET / ORAL	BX	2025-05-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218107-004	RIVAROXABAN	20MG	TABLET / ORAL	BX	2025-05-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218107-001	BX	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218107-002	BX	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218107-003	BX	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218107-004	BX	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218107-001	BX	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218107-002	BX	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218107-003	BX	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218107-004	BX	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218107-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218107-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218107-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218107-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218107-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218107-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218107-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218107-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218107-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218107-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218107-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218107-004	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218107-001	BX	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218107-002	BX	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218107-003	BX	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218107-004	BX	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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RIVAROXABAN	RIVAROXABAN	Camber Pharmaceuticals, Inc.	45f16f1b-e405-4aa6-bc8b-977d4864af3e	2025-05-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RIVAROXABAN generic name: RIVAROXABAN
Xarelto	RIVAROXABAN	A-S Medication Solutions	e76bf2cf-a8b8-4471-a8ce-57c918b11a48	2024-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RIVAROXABAN
Xarelto	RIVAROXABAN	A-S Medication Solutions	65727928-9421-4df8-bff2-f72a9cc78069	2024-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RIVAROXABAN
Xarelto	RIVAROXABAN	A-S Medication Solutions	7e9ab975-db2f-423c-a089-bc5a73313609	2024-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RIVAROXABAN
XARELTO	RIVAROXABAN	A-S Medication Solutions	3e95389b-0a93-4560-98c5-02637fb2600f	2023-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RIVAROXABAN
Xarelto	RIVAROXABAN	Aphena Pharma Solutions - Tennessee, LLC	38b11f5d-f0fc-46dc-aef1-ea31872bb621	2023-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RIVAROXABAN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.