Application 081236

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	450MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A081236-001	THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB		1992-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A081236-001	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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A081236-001	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	1992-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A081236-001	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	1992-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A081236-001	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	1992-11-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A081236-001	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	1992-11-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A081236-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A081236-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A081236-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A081236-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081236-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081236-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081236-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081236-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081236-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081236-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081236-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081236-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081236-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081236-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081236-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081236-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081236-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081236-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081236-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081236-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A081236-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081236-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081236-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081236-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081236-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081236-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081236-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081236-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081236-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081236-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081236-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081236-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A081236-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A081236-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A081236-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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): 081236 application number: ANDA081236 ndc (product): 23155-742

Reported adverse events (FAERS/openFDA)#

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

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
23155-742	Theophylline	Theophylline	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-742	Theophylline	Theophylline	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
50111-518	Theophylline	Theophylline	Teva Pharmaceuticals USA, Inc.	ANDA	Current