Application 090430

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THEOPHYLLINE	THEOPHYLLINE	TABLET, EXTENDED RELEASE;ORAL	300MG	No	No
002	THEOPHYLLINE	THEOPHYLLINE	TABLET, EXTENDED RELEASE;ORAL	450MG	No	Yes

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
A090430-001	THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27
A090430-002	THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090430-001	AB
A090430-002	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 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	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL		RS	2010-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090430-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-10-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090430-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-10-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 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	A090430-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090430-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090430-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090430-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090430-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090430-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090430-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090430-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090430-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090430-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090430-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090430-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090430-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090430-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090430-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090430-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090430-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090430-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090430-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090430-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090430-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090430-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090430-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090430-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090430-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090430-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090430-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090430-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090430-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090430-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090430-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090430-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090430-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090430-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090430-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090430-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090430-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090430-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090430-002	AB	1	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	A090430-001	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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theophylline	THEOPHYLLINE	Alembic Pharmaceuticals Limited	31f3c720-1597-4d43-9296-33017b90b15f	2023-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090430 application number: ANDA090430 ndc (product): 46708-025 ndc (product): 46708-026
Theophylline	THEOPHYLLINE	Alembic Pharmaceuticals Inc.	77e849b8-900b-4f0d-ac5c-1391abcd5721	2021-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090430 application number: ANDA090430 ndc (product): 62332-025 ndc (product): 62332-026

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-025	Theophylline	Theophylline	Alembic Pharmaceuticals Limited	ANDA	Current
46708-025	Theophylline	Theophylline	Alembic Pharmaceuticals Limited	ANDA	Current
46708-025	Theophylline	Theophylline	Alembic Pharmaceuticals Limited	ANDA	Current
46708-026	Theophylline	Theophylline	Alembic Pharmaceuticals Limited	ANDA	Current
46708-026	Theophylline	Theophylline	Alembic Pharmaceuticals Limited	ANDA	Current
46708-026	Theophylline	Theophylline	Alembic Pharmaceuticals Limited	ANDA	Current
53808-0982	Theophylline	Theophylline	State of Florida DOH Central Pharmacy	ANDA	Current
62332-025	Theophylline	Theophylline	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-025	Theophylline	Theophylline	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-025	Theophylline	Theophylline	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-026	Theophylline	Theophylline	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-026	Theophylline	Theophylline	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-026	Theophylline	Theophylline	Alembic Pharmaceuticals Inc.	ANDA	Current
68151-1393	Theophylline	Theophylline	Carilion Materials Management	ANDA	Current