Application 219442

Type: ANDA
Sponsor: BIOCON PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOFACITINIB CITRATE	TOFACITINIB CITRATE	TABLET, EXTENDED RELEASE;ORAL	EQ 11MG BASE	No	No
002	TOFACITINIB CITRATE	TOFACITINIB CITRATE	TABLET, EXTENDED RELEASE;ORAL	EQ 22MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A219442-001	TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2025-11-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219442-001	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
2026-11-14 07:37:17	2026-10	A219442-001	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-17	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A219442-001	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A219442-001	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219442-001	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219442-001	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219442-001	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-17	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219442-001	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	A219442-001	AB	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A219442-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A219442-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219442-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219442-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219442-001	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219442-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOFACITINIB CITRATE	TOFACITINIB CITRATE	Radha Pharmaceuticals, Inc.	141ab3eb-982b-4242-89db-6ddce5be0c40	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOFACITINIB CITRATE generic name: TOFACITINIB CITRATE
TOFACITINIB CITRATE	TOFACITINIB CITRATE	ScieGen Pharmaceuticals, INC.	11d08738-efa3-4474-8eda-812bc04adfbb	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOFACITINIB CITRATE generic name: TOFACITINIB CITRATE
Tofacitinib	TOFACITINIB CITRATE	Breckenridge Pharmaceutical, Inc.	c963c610-52e5-43ab-aac6-3f7e5341b764	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB CITRATE
TOFACITINIB CITRATE	TOFACITINIB CITRATE	Padagis US LLC	df24e90d-4b2c-4f9d-a1d6-fcb1ab00606f	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOFACITINIB CITRATE generic name: TOFACITINIB CITRATE

Reported adverse events (FAERS/openFDA)#

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