Application 019546

Type: NDA
Sponsor: SMITHKLINE BEECHAM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DYNACIRC	ISRADIPINE	CAPSULE;ORAL	2.5MG	Yes	No
002	DYNACIRC	ISRADIPINE	CAPSULE;ORAL	5MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N019546-001	DYNACIRC	ISRADIPINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1990-12-20
N019546-002	DYNACIRC	ISRADIPINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1990-12-20

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N019546-001	DYNACIRC	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1990-12-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N019546-002	DYNACIRC	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1990-12-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019546-001	DYNACIRC	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1990-12-20	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N019546-002	DYNACIRC	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1990-12-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019546-001	DYNACIRC	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1990-12-20	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019546-002	DYNACIRC	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1990-12-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019546-001	DYNACIRC	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1990-12-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019546-002	DYNACIRC	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1990-12-20	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isradipine	ISRADIPINE	AvKARE	fdb4c50e-6e6f-a43d-e053-6294a90aa24f	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: ISRADIPINE
Isradipine	ISRADIPINE	Teva Pharmaceuticals USA, Inc.	bf3425e0-428d-4bdb-ac9a-3b9d483df83a	2023-11-30	Warnings, Adverse reactions	Name fallback generic name: ISRADIPINE
Isradipine	ISRADIPINE	Elite Laboratories, Inc.	acf7c376-6cb6-4857-b455-0bf5da29346c	2019-12-27	Warnings, Adverse reactions	Name fallback generic name: ISRADIPINE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
1380	SUPPL	2005-05-20
40935	ORIG	2002-09-10