Application 218096

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	TOFACITINIB	TOFACITINIB	TABLET	5MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A218096-001	TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB		2026-06-03
A218096-002	TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2026-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A218096-001	AB
A218096-002	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
2026-08-18 06:07:40	2026-07	A218096-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2026-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218096-002	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2026-06-03	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218096-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2026-06-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218096-002	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2026-06-03	`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	A218096-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218096-002	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218096-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218096-002	AB	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tofacitinib	TOFACITINIB	Golden State Medical Supply, Inc.	58f22c41-87d2-e745-e063-6394a90a962e	2026-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218096 application number: ANDA218096
Tofacitinib	TOFACITINIB	Apotex Corp.	7d4f5cfa-35a8-1458-a609-f6b417946abb	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218096 application number: ANDA218096