Application 209738

Type: ANDA
Sponsor: MICRO LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOFACITINIB	TOFACITINIB	TABLET;ORAL	5MG	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
A209738-001	TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB		2023-03-13
A209738-002	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
A209738-001	AB
A209738-002	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	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-03-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209738-002	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2026-06-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209738-002	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	2026-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL		2023-03-13	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209738-001	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-03-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209738-002	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
2026-09-14 22:38:34	2026-08	A209738-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209738-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209738-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209738-002	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209738-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209738-002	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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tofacitinib	TOFACITINIB	Novadoz Pharmaceuticals LLC	253635c8-1ea7-41ba-b216-dea5e3305c47	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tofacitinib generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	Novadoz Pharmaceuticals LLC	327f6b60-1a5d-49e6-acff-18603d0ee9d0	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOFACITINIB generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	Edenbridge Pharmaceuticals LLC.	576722e5-6639-452d-a5c3-33a064f19481	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tofacitinib generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	Golden State Medical Supply, Inc.	58f22c41-87d2-e745-e063-6394a90a962e	2026-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tofacitinib generic name: TOFACITINIB
tofacitinib	TOFACITINIB	Zydus Pharmaceuticals USA Inc.	179ffbb2-bedc-40e6-b77b-33d4f7832172	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: tofacitinib generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	Macleods Pharmaceuticals Limited	9b654f0d-7705-4880-9e9d-ad3a51e56b56	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tofacitinib generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	Apotex Corp.	7d4f5cfa-35a8-1458-a609-f6b417946abb	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tofacitinib generic name: TOFACITINIB
tofacitinib	TOFACITINIB	Zydus Pharmaceuticals USA Inc.	21a89264-8047-40ac-8b10-fa6461072509	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: tofacitinib generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	Sun Pharmaceutical Industries, Inc.	a764a133-b870-4514-bbee-24d43f8cb7fd	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOFACITINIB generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	Apotex Corp.	dd62a2b8-300b-d92b-7b27-a30eaa68fdd3	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tofacitinib generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	AvKARE	5751321a-c904-44ae-e063-6394a90a2654	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tofacitinib generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	Aurobindo Pharma Limited	e54b186f-e42a-4477-939c-8dd331045fbe	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOFACITINIB generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	Aurobindo Pharma Limited	50962b08-99dd-ae73-e063-6394a90ad1eb	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOFACITINIB generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	IPG Pharmaceuticals, Inc	cd1b61bf-de03-4198-89f6-f3952b79d2c2	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOFACITINIB generic name: TOFACITINIB
XELJANZ	TOFACITINIB	U.S. Pharmaceuticals	68e3d6b2-7838-4d2d-a417-09d919b43e13	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
tofacitinib solution	TOFACITINIB	Hikma Pharmaceuticals USA Inc.	d9cf18a9-e825-49ac-b080-68957c0e79ae	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	Orient Pharma Co., Ltd. Yunlin Plant	5617a652-a78e-74b1-e063-6394a90a31c7	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOFACITINIB generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	AvKARE	5502f252-2b39-2cfd-e063-6394a90a8a48	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tofacitinib generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	Ajanta Pharma USA Inc.	024bb9f2-8c26-4d9d-a33b-eb3c0a7c59ed	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tofacitinib generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	Somerset Therapeutics, LLC	2726c2b0-c763-4635-ac6b-4334c3a5a8bc	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOFACITINIB generic name: TOFACITINIB

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57320	ORIG	2019-01-22