Application 208544

Type: ANDA
Sponsor: AUROBINDO 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 1.

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
A208544-001	RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-04-10
A208544-002	RIVAROXABAN	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-15
A208544-003	RIVAROXABAN	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-15
A208544-004	RIVAROXABAN	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208544-001	AB
A208544-002	AB
A208544-003	AB
A208544-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A208544-001	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-04-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208544-002	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208544-003	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208544-004	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A208544-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208544-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208544-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208544-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Rivaroxaban	RIVAROXABAN	Aurobindo Pharma Limited	bcb0e6e7-3006-4d82-8009-c5fddbbfc80d	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208544 application number: ANDA208544

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54786	ORIG	2018-07-06