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 1.

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
2026-02-19 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
2026-07-26 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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOFACITINIB	TOFACITINIB	Micro Labs Limited	ffa6819b-23a4-478b-8fb7-cc90e8142fc5	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209738 application number: ANDA209738

Documents#

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