Application 215552

Type: ANDA
Sponsor: YAOPHARMA CO LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	Tofacitinib	Tofacitinib	TABLET;ORAL	5MG	No	No
002	Tofacitinib	Tofacitinib	TABLET;ORAL	10MG	No	No

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

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
A215552-001	TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB		2026-06-09
A215552-002	TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB		2026-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215552-001	AB
A215552-002	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
2026-09-14 22:38:34	2026-08	A215552-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2026-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215552-002	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2026-06-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215552-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2026-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215552-002	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2026-06-09	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215552-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2026-06-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215552-002	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2026-06-09	`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	A215552-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215552-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215552-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215552-002	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215552-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215552-002	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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tofacitinib	TOFACITINIB	Zydus Lifesciences Limited	f4d0e580-74a8-496e-89a2-d74478c946bf	2026-05-29		Name fallback brand name: tofacitinib generic name: TOFACITINIB
Tofacitinib	TOFACITINIB CITRATE	Breckenridge Pharmaceutical, Inc.	c963c610-52e5-43ab-aac6-3f7e5341b764	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tofacitinib
tofacitinib	TOFACITINIB	Zydus Lifesciences Limited	ac0b26d5-1352-42ff-b5ea-3eb02d8508a4	2026-05-12		Name fallback brand name: tofacitinib generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	Exelan pharmaceuticals,Inc	e68680e5-0328-4e66-b8bb-4af126221ec7	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOFACITINIB generic name: TOFACITINIB
Tofacitinib XR	TOFACITINIB	Biocon Pharma Inc	f0160e3d-63ea-75fb-4b88-fe3d6a6ce030	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB

Reported adverse events (FAERS/openFDA)#

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