Application 212670

Type: ANDA
Sponsor: PAR PHARM INC

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
A212670-001	ZILEUTON	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212670-001	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
2026-02-19 14:30 UTC	2026-02	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212670-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-12-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212670-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212670-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212670-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212670-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212670-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212670-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212670-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212670-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212670-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212670-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212670-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212670-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212670-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212670-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212670-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212670-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212670-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212670-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212670-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212670-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212670-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212670-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212670-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212670-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212670-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212670-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212670-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212670-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212670-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212670-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212670-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212670-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212670-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212670-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212670-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212670-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212670-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zileuton	ZILEUTON	Golden State Medical Supply, Inc.	f7573809-7741-04c9-e053-6294a90ab193	2023-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212670 application number: ANDA212670
Zileuton	ZILEUTON	Strides Pharma Science Limited	a826d16f-df07-447b-b050-b9a02ea1f89e	2022-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212670 application number: ANDA212670 ndc (product): 64380-189

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-723	Zileuton	zileuton	Par Pharmaceutical, Inc.	ANDA	Current
49884-723	Zileuton	zileuton	Par Pharmaceutical, Inc.	ANDA	Current
64380-189	Zileuton	zileuton	Strides Pharma Science Limited	ANDA	Current