Application 214628

Type: NDA
Sponsor: NEVAKAR INJECTABLES, INC.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION	NOREPINEPHRINE IN SODIUM CHLORIDE	INJECTABLE;INJECTION	EQ 250ML BASE/	No	No
002	NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION	NOREPINEPHRINE IN SODIUM CHLORIDE	INJECTABLE;INJECTION	EQ 8MG BASE/250ML	No	No
003	NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION	NOREPINEPHRINE IN SODIUM CHLORIDE	INJECTABLE;INJECTION	EQ 16MG BASE/250ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06
N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06
N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214628-001	10159657	2038-01-30		Drug product	2022-11-02
N214628-001	10226436	2038-01-30	U-3461	Drug product	2022-11-02
N214628-001	10420735	2038-01-30	U-3461	Drug product	2022-11-02
N214628-001	10568850	2038-01-30		Drug product	2022-11-02
N214628-001	11413259	2038-01-30	U-3461	Drug product	2022-11-02
N214628-001	11602508	2038-01-30		Drug product	2023-03-14
N214628-001	12245996	2038-01-30		Drug product	2025-03-26
N214628-002	10159657	2038-01-30		Drug product	2022-11-02
N214628-002	10226436	2038-01-30	U-3461	Drug product	2022-11-02
N214628-002	10420735	2038-01-30	U-3461	Drug product	2022-11-02
N214628-002	10568850	2038-01-30		Drug product	2022-11-02
N214628-002	11413259	2038-01-30	U-3461	Drug product	2022-11-02
N214628-002	11602508	2038-01-30		Drug product	2023-03-14
N214628-002	12245996	2038-01-30		Drug product	2025-03-26
N214628-003	10159657	2038-01-30		Drug product	2022-11-02
N214628-003	10226436	2038-01-30	U-3461	Drug product	2022-11-02
N214628-003	10420735	2038-01-30	U-3461	Drug product	2022-11-02
N214628-003	10568850	2038-01-30		Drug product	2022-11-02
N214628-003	11413259	2038-01-30	U-3461	Drug product	2022-11-02
N214628-003	11602508	2038-01-30		Drug product	2023-03-14
N214628-003	12245996	2038-01-30		Drug product	2025-03-26

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214628-001	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214628-002	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214628-003	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-10-06	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 519 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N214628-001	10159657	2038-01-30		Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-001	10226436	2038-01-30	U-3461	Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-001	10420735	2038-01-30	U-3461	Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-001	10568850	2038-01-30		Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-001	11413259	2038-01-30	U-3461	Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-001	11602508	2038-01-30		Drug product	2023-03-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-001	12245996	2038-01-30		Drug product	2025-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-002	10159657	2038-01-30		Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-002	10226436	2038-01-30	U-3461	Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-002	10420735	2038-01-30	U-3461	Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-002	10568850	2038-01-30		Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-002	11413259	2038-01-30	U-3461	Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-002	11602508	2038-01-30		Drug product	2023-03-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-002	12245996	2038-01-30		Drug product	2025-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-003	10159657	2038-01-30		Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-003	10226436	2038-01-30	U-3461	Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-003	10420735	2038-01-30	U-3461	Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-003	10568850	2038-01-30		Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-003	11413259	2038-01-30	U-3461	Drug product	2022-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-003	11602508	2038-01-30		Drug product	2023-03-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214628-003	12245996	2038-01-30		Drug product	2025-03-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N214628-001	10159657	2038-01-30		Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-001	10226436	2038-01-30	U-3461	Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-001	10420735	2038-01-30	U-3461	Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-001	10568850	2038-01-30		Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-001	11413259	2038-01-30	U-3461	Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-001	11602508	2038-01-30		Drug product	2023-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-001	12245996	2038-01-30		Drug product	2025-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-002	10159657	2038-01-30		Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-002	10226436	2038-01-30	U-3461	Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-002	10420735	2038-01-30	U-3461	Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-002	10568850	2038-01-30		Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-002	11413259	2038-01-30	U-3461	Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-002	11602508	2038-01-30		Drug product	2023-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-002	12245996	2038-01-30		Drug product	2025-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-003	10159657	2038-01-30		Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-003	10226436	2038-01-30	U-3461	Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-003	10420735	2038-01-30	U-3461	Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-003	10568850	2038-01-30		Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214628-003	11413259	2038-01-30	U-3461	Drug product	2022-11-02	`84e616aacf4f…`

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
Norepinephrine	NOREPINEPHRINE BITARTRATE	Long Grove Pharmaceuticals, LLC	759807dd-61a8-4f6f-8bf5-f6ee773c81bc	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214628 application number: NDA214628

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
42023-245	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE IN SODIUM CHLORIDE	Par Pharmaceutical, Inc.	NDA	Current
42023-246	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE in Sodium Chloride	Par Pharmaceutical, Inc.	NDA	Current
42023-247	NOREPINEPHRINE BITARTRATE	Norepinephrine in Sodium Chloride	Par Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80534	SUPPL	2024-12-06
80533	SUPPL	2024-12-06
75305	ORIG	2023-08-28
72276	ORIG	2022-10-07