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 43.

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
2026-09-14 22:38:34	2026-08	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216341-001	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2022-07-19	`caaa826d4ba7…`
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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norepinephrine Bitartrate	NOREPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	dfed53ef-2060-44b8-a62e-9f8ee10a05a5	2023-06-05	Warnings, Adverse reactions	Name fallback brand name: Norepinephrine Bitartrate generic name: NOREPINEPHRINE BITARTRATE
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	Civica, Inc.	4408987e-690a-41ac-9677-e24604fa9793	2023-03-31	Warnings, Adverse reactions	Name fallback brand name: NOREPINEPHRINE BITARTRATE generic name: NOREPINEPHRINE BITARTRATE
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	Sandoz Inc	728734e7-1684-4b37-980c-f1dfd408b436	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: NOREPINEPHRINE BITARTRATE generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine bitartrate	NOREPINEPHRINE BITARTRATE	Mylan Institutional LLC	d3ea12e0-88cc-49b0-b06e-5199ecd6ca69	2021-10-15	Warnings, Adverse reactions	Name fallback brand name: Norepinephrine bitartrate generic name: NOREPINEPHRINE BITARTRATE
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	Sun Pharmaceutical Industries, Inc.	4bb42f07-a41e-42f3-92e7-dab665584f84	2021-07-01	Warnings, Adverse reactions	Name fallback brand name: NOREPINEPHRINE BITARTRATE generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine Bitartrate	NOREPINEPHRINE BITARTRATE	Baxter Healthcare Company	e375a0b9-4d26-4749-bbc3-43d63a7cf65a	2021-05-06	Warnings, Adverse reactions	Name fallback brand name: Norepinephrine Bitartrate generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine bitartrate	NOREPINEPHRINE BITARTRATE	Mylan Institutional LLC	7a4950ea-6369-4dd5-97be-df21a5a5055f	2021-03-05	Warnings, Adverse reactions	Name fallback brand name: Norepinephrine bitartrate generic name: NOREPINEPHRINE BITARTRATE
Norepinephrine Bitartrate	NOREPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	c297757e-35ff-4f39-bccd-61002ac51e23	2020-12-02	Warnings, Adverse reactions	Name fallback brand name: Norepinephrine Bitartrate generic name: NOREPINEPHRINE BITARTRATE

Reported adverse events (FAERS/openFDA)#

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