Application 089763

Type: ANDA
Sponsor: HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THEOPHYLLINE	THEOPHYLLINE	TABLET, EXTENDED RELEASE;ORAL	300MG	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
A089763-001	THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		1990-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089763-001	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.

Product history page 1 of 2 · 41 observed 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	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL		1990-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL		1990-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL		1990-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL		1990-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL		1990-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089763-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1990-04-30	`cb3db0bc1861…`

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	A089763-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089763-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089763-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089763-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089763-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089763-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089763-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089763-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089763-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089763-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089763-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089763-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089763-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089763-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089763-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089763-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089763-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089763-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089763-001	AB	1	`bb7c543d1eb4…`
2019-12-14 00:12 UTC	2019-12	A089763-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089763-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089763-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089763-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089763-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089763-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089763-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089763-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089763-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089763-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089763-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089763-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089763-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089763-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089763-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089763-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A089763-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theophylline	THEOPHYLLINE	AvKARE	f93e20b1-97aa-088d-e053-6394a90a25d4	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089763 application number: ANDA089763
Theophylline	THEOPHYLLINE	Chartwell RX, LLC	9591d4db-2b88-4f0f-b61e-64ba67626e3d	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089763 application number: ANDA089763
Theophylline	THEOPHYLLINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	701fbf9c-e06b-46f4-863b-981acf3021aa	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089763 application number: ANDA089763 ndc (product): 23155-741

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-1590	Theophylline Extended Release	Theophylline, anhydrous	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
23155-741	Theophylline	Theophylline	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
50111-459	Theophylline	Theophylline	Teva Pharmaceuticals USA, Inc.	ANDA	Current
53808-0316	Theophylline	Theophylline	State of Florida DOH Central Pharmacy	ANDA	Current
63629-5198	Theophylline	Theophylline	Bryant Ranch Prepack	ANDA	Current