Application 216341

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A216341-001	NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION			2022-07-19

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2022-07-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2022-07-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2022-07-19	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216341-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216341-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216341-001	AP	1	`e64feba35796…`

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	HF Acquisition Co LLC, DBA HealthFirst	c90d875c-8e6e-284e-e053-2a95a90a334f	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: NOREPINEPHRINE BITARTRATE generic name: NOREPINEPHRINE BITARTRATE
NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE	NOREPINEPHRINE BITARTRATE	WG Critical Care, LLC	ddbef60d-c20a-4ada-928f-e87074c08a54	2026-02-17	Warnings, Adverse reactions	Name fallback generic name: NOREPINEPHRINE BITARTRATE
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	Baxter Healthcare Corporation	6363e9b4-29df-4553-904d-a563e5adda6e	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: NOREPINEPHRINE BITARTRATE generic name: NOREPINEPHRINE BITARTRATE
norepinephrine bitartrate	NOREPINEPHRINE BITARTRATE	Avenacy, LLC	dd4b7827-2fe9-4427-a40a-60f275611bf4	2026-02-01	Warnings, Adverse reactions	Name fallback brand name: norepinephrine bitartrate generic name: NOREPINEPHRINE BITARTRATE
norepinephrine bitartrate	NOREPINEPHRINE BITARTRATE	Novadoz Pharmaceuticals LLC	4b054c27-ed64-40e2-8eba-b7f2ec780a82	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: norepinephrine bitartrate generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine	NOREPINEPHRINE BITARTRATE	Long Grove Pharmaceuticals, LLC	759807dd-61a8-4f6f-8bf5-f6ee773c81bc	2025-12-04	Warnings, Adverse reactions	Name fallback generic name: NOREPINEPHRINE BITARTRATE
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	Anthea Pharma Private Limited	52e22892-4fc3-4f53-9f39-0b5c66da3040	2025-11-25	Warnings, Adverse reactions	Name fallback brand name: NOREPINEPHRINE BITARTRATE generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine Bitartrate	NOREPINEPHRINE BITARTRATE	Breckenridge Pharmaceutical, Inc.	109aa5e6-4e42-4131-97b0-f24d3a4cb4e8	2025-10-06	Warnings, Adverse reactions	Name fallback brand name: Norepinephrine Bitartrate generic name: NOREPINEPHRINE BITARTRATE
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	BIOCON PHARMA INC.	0ea48ab6-e166-df31-b132-70ef982a2d02	2025-06-17	Warnings, Adverse reactions	Name fallback brand name: NOREPINEPHRINE BITARTRATE generic name: NOREPINEPHRINE BITARTRATE
LEVOPHED	NOREPINEPHRINE BITARTRATE	Hospira, Inc.	2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10	2025-06-12	Warnings, Adverse reactions	Name fallback generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine bitartrate	NOREPINEPHRINE BITARTRATE	Camber Pharmaceuticals, Inc.	baba1002-8b62-4a24-a4e1-53e7a59c785a	2025-06-12	Warnings, Adverse reactions	Name fallback brand name: Norepinephrine bitartrate generic name: NOREPINEPHRINE BITARTRATE
LEVOPHED	NOREPINEPHRINE BITARTRATE	Hospira, Inc.	c4de72a8-2a75-4984-ce90-e4870226dc12	2025-06-12	Warnings, Adverse reactions	Name fallback generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine Bitartrate	NOREPINEPHRINE BITARTRATE	Amneal Pharmaceuticals LLC	256264b1-ddf6-42b7-8a09-194fffea65e2	2025-04-24	Warnings, Adverse reactions	Name fallback brand name: Norepinephrine Bitartrate generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine Bitartrate	NOREPINEPHRINE BITARTRATE	Rising Pharma Holdings, Inc.	e6669ed6-9ebc-4b2d-9a8c-5e318fbd18b4	2024-11-01	Warnings, Adverse reactions	Name fallback brand name: Norepinephrine Bitartrate generic name: NOREPINEPHRINE BITARTRATE
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	Caplin Steriles Limited	2ffda6e7-d45d-4af3-a3b1-250a4c95e736	2024-09-28	Warnings, Adverse reactions	Name fallback brand name: NOREPINEPHRINE BITARTRATE generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine Bitartrate	NOREPINEPHRINE BITARTRATE	Meitheal Pharmaceuticals Inc.	53578ac5-b510-4698-a097-f785bfea9fc0	2024-06-24	Warnings, Adverse reactions	Name fallback brand name: Norepinephrine Bitartrate generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine bitartrate	NOREPINEPHRINE BITARTRATE	Gland Pharma Limited	dec04acd-8e66-43c7-80b0-468802eba093	2024-05-24	Warnings, Adverse reactions	Name fallback brand name: Norepinephrine bitartrate generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine Bitartrate	NOREPINEPHRINE BITARTRATE	Hikma Pharmaceuticals USA Inc.	39cda6c6-3857-4028-80cf-aef135f8c7e6	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Norepinephrine Bitartrate generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine Bitartrate	NOREPINEPHRINE BITARTRATE	Sagent Pharmaceuticals	cc9ecec5-3bd7-4132-9745-7666bac8ceac	2023-12-31	Warnings, Adverse reactions	Name fallback brand name: Norepinephrine Bitartrate generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine Bitartrate	NOREPINEPHRINE BITARTRATE	BE Pharmaceuticals Inc.	c42d425a-094e-4390-b4f9-4bb4b0fbc7d0	2023-12-30	Warnings, Adverse reactions	Name fallback brand name: Norepinephrine Bitartrate generic name: NOREPINEPHRINE BITARTRATE