Application 019790

Type: NDA
Sponsor: AUXILIUM PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILATRATE-SR	ISOSORBIDE DINITRATE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	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
N019790-001	DILATRATE-SR	ISOSORBIDE DINITRATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1988-09-02

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1988-09-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1988-09-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1988-09-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1988-09-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1988-09-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019790-001	DILATRATE-SR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1988-09-02	`f41ea6bd6efb…`

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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide	ISOSORBIDE DINITRATE	BluePoint Laboratories	9498fa14-1614-4a8e-b872-41c11745b01e	2018-11-30	Warnings, Adverse reactions	Name fallback generic name: ISOSORBIDE DINITRATE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52244-920	Dilatrate	Isosorbide Dinitrate	Endo Pharmaceuticals, Inc.	NDA	Current
52244-920	Dilatrate	Isosorbide Dinitrate	Endo Pharmaceuticals Inc.	NDA	Current
52244-920	Dilatrate	Isosorbide Dinitrate	Endo Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
33955	SUPPL	2014-11-18
19225	SUPPL	2014-10-27