Application 216007

Type: ANDA
Sponsor: CHENGDU SHUODE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NALMEFENE HYDROCHLORIDE	NALMEFENE HYDROCHLORIDE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	No	Yes
002	NALMEFENE HYDROCHLORIDE	NALMEFENE HYDROCHLORIDE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	No	No
003	NALMEFENE HYDROCHLORIDE	NALMEFENE HYDROCHLORIDE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	2MG BASE/2ML (EQ 1MGBASE/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216007-001	NALMEFENE HYDROCHLORIDE	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15
A216007-002	NALMEFENE HYDROCHLORIDE	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A216007-002	AP

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2023-11-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2023-11-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2023-11-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2023-11-15	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2023-11-15	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2023-11-15	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216007-001	NALMEFENE HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RS	2023-11-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216007-002	NALMEFENE HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2023-11-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216007-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216007-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216007-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216007-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216007-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216007-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216007-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216007-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216007-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216007-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216007-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216007-002	AP	1	`301d65b070ca…`
2024-05-31 18:47 UTC	2024-05	A216007-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216007-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216007-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216007-002	AP	1	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216007-002	AP	1	`a50c72e98297…`

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
nalmefene hydrochloride	NALMEFENE HYDROCHLORIDE INJECTION	Chengdu Shuode Pharmaceutical Co., Ltd	22d67228-6c24-47ca-afc7-52ef279520a0	2023-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216007 application number: ANDA216007