Application 206309

Type: ANDA
Sponsor: RISING

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
A206309-001	TEMOZOLOMIDE	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-27
A206309-002	TEMOZOLOMIDE	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-27
A206309-003	TEMOZOLOMIDE	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-27
A206309-004	TEMOZOLOMIDE	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-27
A206309-005	TEMOZOLOMIDE	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-04-27
A206309-006	TEMOZOLOMIDE	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206309-001	AB
A206309-002	AB
A206309-003	AB
A206309-004	AB
A206309-005	AB
A206309-006	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	A206309-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206309-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206309-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206309-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206309-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206309-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206309-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206309-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206309-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206309-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206309-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206309-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206309-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206309-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206309-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206309-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206309-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206309-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206309-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206309-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206309-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206309-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206309-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206309-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206309-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206309-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206309-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206309-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206309-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206309-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206309-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206309-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206309-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206309-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206309-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206309-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206309-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206309-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206309-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206309-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-04-27	`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	A206309-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206309-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206309-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206309-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206309-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206309-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206309-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206309-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206309-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206309-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206309-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206309-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206309-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206309-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206309-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206309-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206309-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206309-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206309-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206309-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206309-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206309-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206309-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206309-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206309-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206309-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206309-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206309-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206309-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206309-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206309-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206309-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206309-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206309-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206309-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206309-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206309-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206309-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206309-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206309-004	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TEMOZOLOMIDE	TEMOZOLOMIDE	Rising Pharma Holdings, Inc.	70996a9d-4a4f-4ed1-ab07-130486aa14ab	2024-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206309 application number: ANDA206309 ndc (product): 16571-816 ndc (product): 16571-821 ndc (product): 16571-820 ndc (product): 16571-818 ndc (product): 16571-819 ndc (product): 16571-817

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
16571-816	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-816	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-817	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-817	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-818	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-818	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-819	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-819	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-820	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-820	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-821	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-821	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-333	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-334	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-335	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-336	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-337	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-338	TEMOZOLOMIDE	temozolomide	Rising Pharmaceuticals, Inc.	ANDA	Current