Application 086826

Type: ANDA
Sponsor: FOREST LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELIXOPHYLLIN SR	THEOPHYLLINE	CAPSULE, EXTENDED RELEASE;ORAL	125MG	No	No
002	ELIXOPHYLLIN SR	THEOPHYLLINE	CAPSULE, EXTENDED RELEASE;ORAL	250MG	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
A086826-001	ELIXOPHYLLIN SR	THEOPHYLLINE	125MG	CAPSULE, EXTENDED RELEASE / ORAL			1985-01-29
A086826-002	ELIXOPHYLLIN SR	THEOPHYLLINE	250MG	CAPSULE, EXTENDED RELEASE / ORAL			1985-01-29

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086826-001	ELIXOPHYLLIN SR	125MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086826-002	ELIXOPHYLLIN SR	250MG	CAPSULE, EXTENDED RELEASE / ORAL	1985-01-29	`74a2ff9319b5…`

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theophylline	THEOPHYLLINE	Harman Finochem Limited	098db8bb-fa9a-4577-b7d9-86caaefc168a	2024-04-27	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Bionpharma Inc.,	63517422-45a0-4e78-8505-eca054068ee9	2023-10-12	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Camber Pharmaceuticals, Inc.	bf320619-c53b-49a7-97b5-cd0c075a9f75	2023-09-20	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Alembic Pharmaceuticals Limited	31f3c720-1597-4d43-9296-33017b90b15f	2023-01-11	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Teva Pharmaceuticals, Inc.	25eabefa-518b-4030-9b72-01ac8b3deba9	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Alembic Pharmaceuticals Inc.	77e849b8-900b-4f0d-ac5c-1391abcd5721	2021-10-01	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE

Reported adverse events (FAERS/openFDA)#

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