Application 016796

Type: NDA
Sponsor: AKORN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INAPSINE	DROPERIDOL	INJECTABLE;INJECTION	2.5MG/ML	Yes	Yes

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

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
N016796-001	INAPSINE	DROPERIDOL	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N016796-001	INAPSINE	2.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016796-001	INAPSINE	2.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016796-001	INAPSINE	2.5MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016796-001	INAPSINE	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016796-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016796-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016796-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016796-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016796-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016796-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016796-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016796-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016796-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016796-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016796-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016796-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016796-001	AP	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016796-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016796-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016796-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016796-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016796-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016796-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016796-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016796-001	AP	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Droperidol	DROPERIDOL	American Regent, Inc.	147e033d-d997-4ef6-8bb5-a9ba372590b2	2023-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DROPERIDOL
DROPERIDOL	DROPERIDOL	Hikma Pharmaceuticals USA Inc.	d89f33ac-8a6e-49e7-94fb-84e58aad65a8	2022-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DROPERIDOL

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
496	SUPPL	2003-06-16