Application 211390

Type: ANDA
Sponsor: AIZANT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZILEUTON	ZILEUTON	TABLET, EXTENDED RELEASE;ORAL	600MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A211390-001	ZILEUTON	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-10-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211390-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A211390-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-10-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A211390-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZYFLO	ZILEUTON	Chiesi USA, Inc.	aee65202-fddb-497f-9f11-17cc727cb157	2025-11-30	Warnings, Adverse reactions	Name fallback generic name: ZILEUTON
Zileuton	ZILEUTON	Rising Pharma Holdings, Inc.	fd382540-b390-4e86-a94a-988ea89c93a8	2024-05-15	Warnings, Adverse reactions	Name fallback brand name: Zileuton generic name: ZILEUTON
Zileuton	ZILEUTON	NorthStar RxLLC	bc29c998-1324-46aa-8386-e5b2fc9e0b16	2024-05-02	Warnings, Adverse reactions	Name fallback brand name: Zileuton generic name: ZILEUTON
Zileuton	ZILEUTON	Golden State Medical Supply, Inc.	f7573809-7741-04c9-e053-6294a90ab193	2023-03-20	Warnings, Adverse reactions	Name fallback brand name: Zileuton generic name: ZILEUTON
Zileuton	ZILEUTON	Camber Pharmaceuticals, Inc.	94313e24-9534-4b6c-b374-c436c4916303	2022-10-14	Warnings, Adverse reactions	Name fallback brand name: Zileuton generic name: ZILEUTON
Zileuton	ZILEUTON	Strides Pharma Science Limited	a826d16f-df07-447b-b050-b9a02ea1f89e	2022-07-29	Warnings, Adverse reactions	Name fallback brand name: Zileuton generic name: ZILEUTON

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69339-130	Zileuton	zileuton	DASH Pharmaceutical LLC	ANDA	Current
69339-130	Zileuton	zileuton	DASH Pharmaceutical LLC	ANDA	Current
69339-130	Zileuton	zileuton	DASH Pharmaceutical LLC	ANDA	Current
69339-130	Zileuton	zileuton	DASH Pharmaceutical LLC	ANDA	Current