Application 085863

Type: ANDA
Sponsor: PRECISION DOSE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THEOPHYLLINE	THEOPHYLLINE	ELIXIR;ORAL	80MG/15ML	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
A085863-001	THEOPHYLLINE	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL		RLD, Approved before 1982

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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085863-001	THEOPHYLLINE	80MG/15ML	ELIXIR / ORAL	RLD, Approved before 1982	`cb3db0bc1861…`

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theophylline	THEOPHYLLINE	PD-Rx Pharmaceuticals, Inc.	c6ca5cc9-4e5e-40cf-a36e-227aa4cb55c6	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	PD-Rx Pharmaceuticals, Inc.	5e64036a-ee3e-42e7-9e59-881f88a4e298	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
Theophylline (Anhydrous)	THEOPHYLLINE	Golden State Medical Supply, Inc.	aa80b9f4-8a5d-3e14-e053-2a95a90a8aab	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
theophylline	THEOPHYLLINE	Amneal Pharmaceuticals NY LLC	b0d5d1cd-c79b-4229-929c-2eb3e4f43298	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: theophylline generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Strides Pharma Science Limited	b7a90ccf-9c32-40cc-9008-7e55b3da4dfd	2026-03-10	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Chartwell RX, LLC	1b685384-5d96-46fa-b93b-e96538a2cfe7	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Glenmark Pharmaceuticals Inc., USA	48330a8e-be08-4d38-b8b1-d30fbd5a35de	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Glenmark Pharmaceuticals Inc., USA	56fc2167-ceb6-4e3e-8ff7-5e400dfbd533	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	AvKARE	f93e20b1-97aa-088d-e053-6394a90a25d4	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Chartwell RX, LLC	9591d4db-2b88-4f0f-b61e-64ba67626e3d	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	ATLANTIC BIOLOGICALS CORP.	47e484c2-f59e-4a71-bb97-c90f128ac345	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Ajanta Pharma USA Inc.	7a422c32-bbdf-4297-84f4-9c438c904b0c	2025-11-30	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Chartwell Governmental & Specialty RX, LLC.	e2716dac-8b23-4e06-bc3e-4dd76b7c813e	2025-11-14	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Bryant Ranch Prepack	62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	701fbf9c-e06b-46f4-863b-981acf3021aa	2025-07-10	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Bryant Ranch Prepack	955dba5e-c3b7-4a45-8650-e1b4722dbaea	2024-11-20	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
THEOPHYLLINE	THEOPHYLLINE	PAI Holdings, LLC dba PAI Pharma	32b9780f-c46f-4e0f-9641-2cab60600e6e	2024-11-19	Warnings, Adverse reactions	Name fallback brand name: THEOPHYLLINE generic name: THEOPHYLLINE
THEOPHYLLINE	THEOPHYLLINE	Leading Pharma, LLC	ac490ebf-24e1-47c4-a932-ad4dcafe7aad	2024-10-07	Warnings, Adverse reactions	Name fallback brand name: THEOPHYLLINE generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Cranbury Pharmaceuticals, LLC	78a99bfe-6ebe-4ace-80b0-ee019921435e	2024-08-30	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Viona Pharmaceuticals Inc	abdfb9b9-9402-4761-9347-8eb1c4d86242	2024-05-22	Warnings, Adverse reactions	Name fallback brand name: Theophylline generic name: THEOPHYLLINE

Application 085863

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#