Application 020981

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYCAMTIN	TOPOTECAN HYDROCHLORIDE	CAPSULE;ORAL	EQ 0.25MG BASE	Yes	No
002	HYCAMTIN	TOPOTECAN HYDROCHLORIDE	CAPSULE;ORAL	EQ 1MG BASE	Yes	Yes

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

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
N020981-001	HYCAMTIN	TOPOTECAN HYDROCHLORIDE	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2007-10-11
N020981-002	HYCAMTIN	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE / ORAL		RLD, RS	2007-10-11

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 · 84 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	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020981-001	HYCAMTIN	EQ 0.25MG BASE	CAPSULE / ORAL	RLD	2007-10-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020981-002	HYCAMTIN	EQ 1MG BASE	CAPSULE / ORAL	RLD, RS	2007-10-11	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020981-002	8158645	2024-12-10	Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020981-002	8158645	2024-12-10	Drug product		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020981-002	8158645	2024-12-10	Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020981-002	8158645	2024-12-10	Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020981-002	8158645	2024-12-10	Drug product		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020981-002	8158645	2024-12-10	Drug product		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020981-002	8158645	2024-12-10	Drug product		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020981-002	8158645	2024-12-10	Drug product		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020981-002	8158645	2024-12-10	Drug product		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020981-002	8158645	2024-12-10	Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020981-002	8158645	2024-12-10	Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020981-002	8158645	2024-12-10	Drug product		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020981-002	8158645	2024-12-10	Drug product		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020981-002	8158645	2024-12-10	Drug product		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020981-002	8158645	2024-12-10	Drug product		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020981-002	8158645	2024-12-10	Drug product		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020981-002	8158645	2024-12-10	Drug product		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020981-002	8158645	2024-12-10	Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020981-002	8158645	2024-12-10	Drug product		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020981-001	8158645	2024-12-10	Drug product	2012-05-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020981-002	8158645	2024-12-10	Drug product		`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYCAMTIN	TOPOTECAN	Sandoz Inc	b23b46f5-c276-47f5-8bbd-940680b3f579	2023-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020981 application number: NDA020981

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0672	HYCAMTIN	topotecan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0672	HYCAMTIN	topotecan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0672	HYCAMTIN	topotecan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0672	HYCAMTIN	topotecan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0672	HYCAMTIN	topotecan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0673	HYCAMTIN	topotecan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0673	HYCAMTIN	topotecan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0673	HYCAMTIN	topotecan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0673	HYCAMTIN	topotecan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0673	HYCAMTIN	topotecan	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55453	SUPPL	2018-09-12
55391	SUPPL	2018-09-06
35783	SUPPL	2014-06-23
26372	SUPPL	2014-06-19
14081	SUPPL	2011-10-12
3930	SUPPL	2011-10-12
14080	SUPPL	2010-07-06
3929	SUPPL	2010-07-02
44634	ORIG	2009-01-15
21325	ORIG	2009-01-15
26371	ORIG	2007-10-22
14079	ORIG	2007-10-12