Application 017751

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	DURANEST	ETIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	DURANEST	EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.005MG/ML;0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	DURANEST	ETIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
006	DURANEST	EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.005MG/ML;1% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
007	DURANEST	EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.005MG/ML;1.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N017751-003	DURANEST	ETIDOCAINE HYDROCHLORIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N017751-004	DURANEST	EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE	0.005MG/ML;0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N017751-005	DURANEST	ETIDOCAINE HYDROCHLORIDE	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N017751-006	DURANEST	EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE	0.005MG/ML;1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N017751-007	DURANEST	EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE	0.005MG/ML;1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982

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 6 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N017751-003	DURANEST	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N017751-004	DURANEST	0.005MG/ML;0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N017751-005	DURANEST	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N017751-006	DURANEST	0.005MG/ML;1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N017751-007	DURANEST	0.005MG/ML;1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017751-003	DURANEST	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017751-004	DURANEST	0.005MG/ML;0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017751-005	DURANEST	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017751-006	DURANEST	0.005MG/ML;1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017751-007	DURANEST	0.005MG/ML;1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017751-003	DURANEST	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017751-004	DURANEST	0.005MG/ML;0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017751-005	DURANEST	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017751-006	DURANEST	0.005MG/ML;1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017751-007	DURANEST	0.005MG/ML;1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Application 017751

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#