Application 087400

Type: ANDA
Sponsor: NOSTRUM PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	THEOCHRON	THEOPHYLLINE	TABLET, EXTENDED RELEASE;ORAL	300MG	No	No
003	THEOCHRON	THEOPHYLLINE	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No
004	THEOCHRON	THEOPHYLLINE	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No
005	THEOPHYLLINE	THEOPHYLLINE	TABLET, EXTENDED RELEASE;ORAL	450MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A087400-002	THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11
A087400-003	THEOPHYLLINE	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21
A087400-004	THEOPHYLLINE	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21
A087400-005	THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A087400-002	AB
A087400-005	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 4 · 143 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	A087400-002	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087400-003	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087400-004	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087400-005	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087400-002	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087400-003	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087400-004	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087400-005	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087400-002	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087400-003	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087400-004	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087400-005	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087400-002	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087400-003	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087400-004	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087400-005	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087400-002	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087400-003	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087400-004	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087400-005	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087400-002	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087400-003	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087400-004	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087400-005	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087400-002	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087400-003	THEOPHYLLINE	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087400-004	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087400-005	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087400-002	THEOCHRON	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087400-003	THEOCHRON	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087400-004	THEOCHRON	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087400-005	THEOCHRON	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087400-002	THEOCHRON	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087400-003	THEOCHRON	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087400-004	THEOCHRON	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087400-005	THEOCHRON	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087400-002	THEOCHRON	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	1983-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087400-003	THEOCHRON	100MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087400-004	THEOCHRON	200MG	TABLET, EXTENDED RELEASE / ORAL		1985-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087400-005	THEOCHRON	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-08-09	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 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	A087400-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087400-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087400-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087400-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087400-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087400-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087400-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087400-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087400-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087400-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087400-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087400-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087400-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087400-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087400-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087400-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087400-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087400-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087400-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087400-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087400-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087400-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087400-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087400-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087400-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087400-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087400-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A087400-005	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A087400-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A087400-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087400-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087400-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087400-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A087400-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087400-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A087400-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087400-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A087400-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087400-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A087400-004	AB	1	`3f01610625f2…`

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 generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	PD-Rx Pharmaceuticals, Inc.	5e64036a-ee3e-42e7-9e59-881f88a4e298	2026-07-29	Warnings, Adverse reactions	Name fallback 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 generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Strides Pharma Science Limited	b7a90ccf-9c32-40cc-9008-7e55b3da4dfd	2026-03-10	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Chartwell RX, LLC	1b685384-5d96-46fa-b93b-e96538a2cfe7	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Glenmark Pharmaceuticals Inc., USA	48330a8e-be08-4d38-b8b1-d30fbd5a35de	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Glenmark Pharmaceuticals Inc., USA	56fc2167-ceb6-4e3e-8ff7-5e400dfbd533	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	AvKARE	f93e20b1-97aa-088d-e053-6394a90a25d4	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Chartwell RX, LLC	9591d4db-2b88-4f0f-b61e-64ba67626e3d	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	ATLANTIC BIOLOGICALS CORP.	47e484c2-f59e-4a71-bb97-c90f128ac345	2025-12-04	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Ajanta Pharma USA Inc.	7a422c32-bbdf-4297-84f4-9c438c904b0c	2025-11-30	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Chartwell Governmental & Specialty RX, LLC.	e2716dac-8b23-4e06-bc3e-4dd76b7c813e	2025-11-14	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Bryant Ranch Prepack	62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd	2025-10-22	Warnings, Adverse reactions	Name fallback 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 generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Bryant Ranch Prepack	955dba5e-c3b7-4a45-8650-e1b4722dbaea	2024-11-20	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
THEOPHYLLINE	THEOPHYLLINE	PAI Holdings, LLC dba PAI Pharma	32b9780f-c46f-4e0f-9641-2cab60600e6e	2024-11-19	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
THEOPHYLLINE	THEOPHYLLINE	Leading Pharma, LLC	ac490ebf-24e1-47c4-a932-ad4dcafe7aad	2024-10-07	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Cranbury Pharmaceuticals, LLC	78a99bfe-6ebe-4ace-80b0-ee019921435e	2024-08-30	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Viona Pharmaceuticals Inc	abdfb9b9-9402-4761-9347-8eb1c4d86242	2024-05-22	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE