Application 040560

Type: ANDA
Sponsor: NOSTRUM LABS INC

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	600MG	No	Yes
003	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
A040560-002	THEOPHYLLINE	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21
A040560-003	THEOPHYLLINE	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040560-002	AB
A040560-003	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 3 · 82 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	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040560-002	THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2006-04-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040560-003	THEOPHYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2006-04-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A040560-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040560-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040560-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040560-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040560-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040560-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040560-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040560-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040560-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040560-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040560-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040560-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040560-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040560-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040560-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040560-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040560-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040560-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040560-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040560-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040560-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040560-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040560-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040560-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040560-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040560-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040560-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040560-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040560-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040560-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040560-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040560-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040560-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040560-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040560-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040560-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040560-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040560-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040560-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040560-003	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theophylline (Anhydrous)	THEOPHYLLINE	Golden State Medical Supply, Inc.	aa80b9f4-8a5d-3e14-e053-2a95a90a8aab	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040560 application number: ANDA040560 ndc (product): 51407-318 ndc (product): 51407-319
Theophylline (Anhydrous)	THEOPHYLLINE ANHYDROUS	Westminster Pharmaceuticals, LLC	04f1d1da-ce61-45b3-acf4-903cc81d16da	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040560 application number: ANDA040560

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0486	Theophylline	Theophylline	Mylan Pharamceuticals Inc.	ANDA	Current
0378-0486	Theophylline	Theophylline	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0486	Theophylline	Theophylline	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0487	Theophylline	Theophylline	Mylan Pharamceuticals Inc.	ANDA	Current
0378-0487	Theophylline	Theophylline	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0487	Theophylline	Theophylline	Mylan Pharmaceuticals Inc.	ANDA	Current
29033-001	Theophylline	Theophylline	Nostrum Laboratories, Inc.	ANDA	Current
29033-001	Theophylline	Theophylline	Nostrum Laboratories, Inc.	ANDA	Current
29033-001	Theophylline	Theophylline	Nostrum Laboratories, Inc.	ANDA	Current
29033-002	Theophylline	Theophylline	Nostrum Laboratories, Inc.	ANDA	Current
29033-002	Theophylline	Theophylline	Nostrum Laboratories, Inc.	ANDA	Current
29033-002	Theophylline	Theophylline	Nostrum Laboratories, Inc.	ANDA	Current
51407-318	Theophylline	Theophylline	Golden State Medical Supply	ANDA	Current
51407-318	Theophylline	Theophylline	Golden State Medical Supply, Inc.	ANDA	Current
51407-318	Theophylline	Theophylline	Golden State Medical Supply, Inc.	ANDA	Current
51407-319	Theophylline	Theophylline	Golden State Medical Supply	ANDA	Current
51407-319	Theophylline	Theophylline	Golden State Medical Supply, Inc.	ANDA	Current
51407-319	Theophylline	Theophylline	Golden State Medical Supply, Inc.	ANDA	Current
68151-4210	Theophylline	Theophylline	Carilion Materials Management	ANDA	Current