Application 040086

Type: ANDA
Sponsor: RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THEOPHYLLINE	THEOPHYLLINE	TABLET, EXTENDED RELEASE;ORAL	600MG	No	No
002	THEOPHYLLINE	THEOPHYLLINE	TABLET, EXTENDED RELEASE;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040086-001	THEOPHYLLINE	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15
A040086-002	THEOPHYLLINE	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040086-002	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 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL			1996-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040086-002	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1982-09-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040086-001	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		1996-04-15	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040086-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040086-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040086-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040086-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040086-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040086-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040086-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040086-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040086-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040086-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040086-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040086-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040086-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040086-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040086-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040086-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040086-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040086-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040086-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040086-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040086-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040086-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040086-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040086-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040086-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040086-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040086-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040086-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040086-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040086-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040086-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040086-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040086-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040086-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040086-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040086-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040086-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040086-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040086-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040086-001	AB	1	`6a51e52b5d6a…`

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42858-701	Theophylline	Theophylline	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-701	Theophylline	Theophylline	Rhodes Pharmaceuticals	ANDA	Current
42858-702	Theophylline	Theophylline	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-702	Theophylline	Theophylline	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-702	Theophylline	Theophylline	Rhodes Pharmaceuticals	ANDA	Current
67781-252	Uniphyl	theophylline anhydrous	Purdue Pharmaceutical Products LP	ANDA	Current