Application 207658

Type: ANDA
Sponsor: DEVA HOLDING AS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	5MG	No	No
002	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	20MG	No	No
003	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	100MG	No	No
004	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	140MG	No	No
005	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	180MG	No	No
006	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207658-001	TEMOZOLOMIDE	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26
A207658-002	TEMOZOLOMIDE	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26
A207658-003	TEMOZOLOMIDE	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26
A207658-004	TEMOZOLOMIDE	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26
A207658-005	TEMOZOLOMIDE	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26
A207658-006	TEMOZOLOMIDE	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A207658-001	AB
A207658-002	AB
A207658-003	AB
A207658-004	AB
A207658-005	AB
A207658-006	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 7 · 252 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
2026-08-18 06:07:40	2026-07	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207658-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207658-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207658-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-004	AB	1	`03ed91905a0d…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Temozolomide	TEMOZOLOMIDE	CivicaScript LLC	56245d21-4a42-471e-bbdc-80b129336e2f	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	79766855-2533-43b1-b60e-1e9daecadad5	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	021b97cc-a76f-44b6-b7be-670d2ae83690	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	c0f2077c-48e6-452e-9f88-e1f2c89df0a2	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	38f17780-8037-44a0-9e84-b7150c9bde12	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	6eb0bd33-582f-43a6-a607-e72b4390c6d3	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	a147b361-262c-49c6-9b8e-7e454f755721	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
Temozolomide	TEMOZOLOMIDE	Ascend Laboratories, LLC	33d67bce-38ae-45fc-a858-d51167b0ecfd	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658 ndc (product): 67877-540 ndc (product): 67877-541 ndc (product): 67877-538 ndc (product): 67877-537 ndc (product): 67877-539 ndc (product): 67877-542
Temozolomide	TEMOZOLOMIDE	Devatis, Inc.	6b263fe0-5f06-4889-bf14-4aa185470810	2024-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-537	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-537	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-537	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-538	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-538	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-538	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-539	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-539	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-539	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-540	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-540	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-540	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-541	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-541	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-541	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-542	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-542	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current
67877-542	Temozolomide	Temozolomide	Ascend Laboratories, LLC	ANDA	Current