Application 020892

Type: NDA
Sponsor: ENDO PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALSTAR PRESERVATIVE FREE	VALRUBICIN	SOLUTION;INTRAVESICAL	40MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020892-001	VALSTAR PRESERVATIVE FREE	VALRUBICIN	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020892-001	AO

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 2 · 43 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
2026-09-14 22:38:34	2026-08	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020892-001	VALSTAR PRESERVATIVE FREE	40MG/ML	SOLUTION / INTRAVESICAL	AO	RLD, RS	1998-09-25	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N020892-001	AO	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020892-001	AO	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020892-001	AO	1	`a50c72e98297…`

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
Valstar	VALRUBICIN	Endo USA, Inc.	e96f30a0-6662-11de-8f80-0002a5d5c51b	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020892 application number: NDA020892 ndc (product): 67979-001

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67979-001	Valstar	valrubicin	Endo Pharmaceuticals Solutions Inc.	NDA	Current
67979-001	Valstar	valrubicin	Endo Pharmaceuticals Solutions Inc.	NDA	Current
67979-001	Valstar	valrubicin	Endo Pharmaceuticals Solutions Inc.	NDA	Current
67979-001	Valstar	valrubicin	Endo Pharmaceuticals Inc.	NDA	Current
67979-001	Valstar	valrubicin	Endo Pharmaceuticals Solutions Inc.	NDA	Current
67979-001	Valstar	valrubicin	Endo Pharmaceuticals Inc.	NDA	Current
67979-001	Valstar	valrubicin	Endo Pharmaceuticals Solutions Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
26125	SUPPL	2016-04-11
35576	SUPPL	2016-04-08
3659	SUPPL	2013-08-05
3658	SUPPL	2011-11-07
13674	SUPPL	2011-11-04
21045	ORIG	1998-09-25
13673	ORIG	1998-09-25
3657	ORIG	1998-09-25