Application 021029

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEMODAR	TEMOZOLOMIDE	CAPSULE;ORAL	5MG	Yes	No
002	TEMODAR	TEMOZOLOMIDE	CAPSULE;ORAL	20MG	Yes	No
003	TEMODAR	TEMOZOLOMIDE	CAPSULE;ORAL	100MG	Yes	No
004	TEMODAR	TEMOZOLOMIDE	CAPSULE;ORAL	250MG	Yes	Yes
005	TEMODAR	TEMOZOLOMIDE	CAPSULE;ORAL	140MG	Yes	No
006	TEMODAR	TEMOZOLOMIDE	CAPSULE;ORAL	180MG	Yes	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	RLD / RS	Approval date
N021029-001	TEMODAR	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	RLD	1999-08-11
N021029-002	TEMODAR	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	RLD	1999-08-11
N021029-003	TEMODAR	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	RLD	1999-08-11
N021029-004	TEMODAR	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	RLD	1999-08-11
N021029-005	TEMODAR	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	RLD	2006-10-19
N021029-006	TEMODAR	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	RLD	2006-10-19

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021029-001	TEMODAR	5MG	CAPSULE / ORAL	RLD	1999-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021029-002	TEMODAR	20MG	CAPSULE / ORAL	RLD	1999-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021029-003	TEMODAR	100MG	CAPSULE / ORAL	RLD	1999-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021029-004	TEMODAR	250MG	CAPSULE / ORAL	RLD	1999-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021029-005	TEMODAR	140MG	CAPSULE / ORAL	RLD	2006-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021029-006	TEMODAR	180MG	CAPSULE / ORAL	RLD	2006-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021029-001	TEMODAR	5MG	CAPSULE / ORAL	RLD	1999-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021029-002	TEMODAR	20MG	CAPSULE / ORAL	RLD	1999-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021029-003	TEMODAR	100MG	CAPSULE / ORAL	RLD	1999-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021029-004	TEMODAR	250MG	CAPSULE / ORAL	RLD	1999-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021029-005	TEMODAR	140MG	CAPSULE / ORAL	RLD	2006-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021029-006	TEMODAR	180MG	CAPSULE / ORAL	RLD	2006-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021029-001	TEMODAR	5MG	CAPSULE / ORAL	RLD	1999-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021029-002	TEMODAR	20MG	CAPSULE / ORAL	RLD	1999-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021029-003	TEMODAR	100MG	CAPSULE / ORAL	RLD	1999-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021029-004	TEMODAR	250MG	CAPSULE / ORAL	RLD	1999-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021029-005	TEMODAR	140MG	CAPSULE / ORAL	RLD	2006-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021029-006	TEMODAR	180MG	CAPSULE / ORAL	RLD	2006-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021029-001	TEMODAR	5MG	CAPSULE / ORAL	RLD	1999-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021029-002	TEMODAR	20MG	CAPSULE / ORAL	RLD	1999-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021029-003	TEMODAR	100MG	CAPSULE / ORAL	RLD	1999-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021029-004	TEMODAR	250MG	CAPSULE / ORAL	RLD	1999-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021029-005	TEMODAR	140MG	CAPSULE / ORAL	RLD	2006-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021029-006	TEMODAR	180MG	CAPSULE / ORAL	RLD	2006-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021029-001	TEMODAR	5MG	CAPSULE / ORAL	RLD	1999-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021029-002	TEMODAR	20MG	CAPSULE / ORAL	RLD	1999-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021029-003	TEMODAR	100MG	CAPSULE / ORAL	RLD	1999-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021029-004	TEMODAR	250MG	CAPSULE / ORAL	RLD	1999-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021029-005	TEMODAR	140MG	CAPSULE / ORAL	RLD	2006-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021029-006	TEMODAR	180MG	CAPSULE / ORAL	RLD	2006-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021029-001	TEMODAR	5MG	CAPSULE / ORAL	RLD	1999-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021029-002	TEMODAR	20MG	CAPSULE / ORAL	RLD	1999-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021029-003	TEMODAR	100MG	CAPSULE / ORAL	RLD	1999-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021029-004	TEMODAR	250MG	CAPSULE / ORAL	RLD	1999-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021029-005	TEMODAR	140MG	CAPSULE / ORAL	RLD	2006-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021029-006	TEMODAR	180MG	CAPSULE / ORAL	RLD	2006-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021029-001	TEMODAR	5MG	CAPSULE / ORAL	RLD	1999-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021029-002	TEMODAR	20MG	CAPSULE / ORAL	RLD	1999-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021029-003	TEMODAR	100MG	CAPSULE / ORAL	RLD	1999-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021029-004	TEMODAR	250MG	CAPSULE / ORAL	RLD	1999-08-11	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021029-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021029-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021029-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021029-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021029-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021029-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021029-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021029-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021029-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021029-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021029-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021029-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021029-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021029-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021029-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021029-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021029-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021029-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021029-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021029-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021029-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021029-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021029-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021029-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021029-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021029-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021029-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021029-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021029-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021029-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021029-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021029-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021029-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021029-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021029-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021029-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021029-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021029-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021029-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021029-004	AB	1	`87673890dc5c…`

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
TEMODAR	TEMOZOLOMIDE	Merck Sharp & Dohme LLC	046a9011-3911-4d3f-a15f-fbb56d5aad56	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021029 application number: NDA021029 ndc (product): 0085-1366 ndc (product): 0085-3004 ndc (product): 0085-1430 ndc (product): 0085-1425 ndc (product): 0085-1417 ndc (product): 0085-1519

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 60 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0085-1366	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1366	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1366	TEMODAR	Temozolomide	Merck Sharp & Dohme LLC	NDA	Current
0085-1366	TEMODAR	Temozolomide	Merck Sharp & Dohme LLC	NDA	Current
0085-1366	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1366	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1417	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1417	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1417	TEMODAR	Temozolomide	Merck Sharp & Dohme LLC	NDA	Current
0085-1417	TEMODAR	Temozolomide	Merck Sharp & Dohme LLC	NDA	Current
0085-1417	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1417	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1425	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1425	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1425	TEMODAR	Temozolomide	Merck Sharp & Dohme LLC	NDA	Current
0085-1425	TEMODAR	Temozolomide	Merck Sharp & Dohme LLC	NDA	Current
0085-1425	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1425	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1430	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1430	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1430	TEMODAR	Temozolomide	Merck Sharp & Dohme LLC	NDA	Current
0085-1430	TEMODAR	Temozolomide	Merck Sharp & Dohme LLC	NDA	Current
0085-1430	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1430	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1519	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1519	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1519	TEMODAR	Temozolomide	Merck Sharp & Dohme LLC	NDA	Current
0085-1519	TEMODAR	Temozolomide	Merck Sharp & Dohme LLC	NDA	Current
0085-1519	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1519	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-3004	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-3004	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-3004	TEMODAR	Temozolomide	Merck Sharp & Dohme LLC	NDA	Current
0085-3004	TEMODAR	Temozolomide	Merck Sharp & Dohme LLC	NDA	Current
0085-3004	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0085-3004	TEMODAR	Temozolomide	Merck Sharp & Dohme Corp.	NDA	Current
0781-2691	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2691	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2691	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2691	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2692	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2692	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2692	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2692	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2693	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2693	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2693	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2693	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2694	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2694	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2694	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2694	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2695	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2695	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2695	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2695	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2696	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2696	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2696	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
0781-2696	Temozolomide	Temozolomide	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75594	SUPPL	2023-09-28
75593	SUPPL	2023-09-28
75592	SUPPL	2023-09-28
75482	SUPPL	2023-09-15
75481	SUPPL	2023-09-15
75480	SUPPL	2023-09-15
75459	SUPPL	2023-09-14
75458	SUPPL	2023-09-14
75457	SUPPL	2023-09-14
65319	SUPPL	2020-11-25
65305	SUPPL	2020-11-25
61050	SUPPL	2019-11-26
61046	SUPPL	2019-11-25
50027	SUPPL	2017-10-12
49995	SUPPL	2017-10-10
47430	SUPPL	2017-03-02
47337	SUPPL	2017-02-27
14203	SUPPL	2016-02-18
26535	SUPPL	2016-02-16
14202	SUPPL	2015-09-23
4098	SUPPL	2015-09-22
35936	SUPPL	2015-04-07
26534	SUPPL	2015-04-03
35935	SUPPL	2014-05-06
26533	SUPPL	2014-05-06
35934	SUPPL	2013-01-09
4097	SUPPL	2011-06-09
14201	SUPPL	2011-06-07
14200	SUPPL	2011-02-09
26532	SUPPL	2010-04-29
35933	SUPPL	2010-04-28
35932	SUPPL	2006-10-23
4096	SUPPL	2006-10-23
4095	SUPPL	2006-04-07
4094	SUPPL	2005-04-28
26531	SUPPL	2005-03-31
4093	SUPPL	2005-03-18
14199	SUPPL	2005-03-15
26530	SUPPL	2004-07-21
4092	SUPPL	2004-06-30
41890	SUPPL	2004-04-14
35931	SUPPL	2003-03-26
26529	SUPPL	2003-03-26
26528	SUPPL	2002-01-18
14198	SUPPL	2002-01-18
41889	ORIG	1999-08-11
35930	ORIG	1999-08-11
26527	ORIG	1999-08-11
52217	SUPPL	1900-01-01
52216	SUPPL	1900-01-01
52215	SUPPL	1900-01-01
52214	SUPPL	1900-01-01
52213	SUPPL	1900-01-01