Application 207595

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/ML	No	No
002	NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE	INJECTABLE;INJECTION	20MG/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207595-001	NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2019-01-11
A207595-002	NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE	20MG/ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			2019-01-11

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 1 of 3 · 86 observed 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	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2019-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2019-01-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2019-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2019-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2019-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2019-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2019-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2019-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2019-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		2019-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2019-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2019-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2019-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2019-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2019-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2019-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2019-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2019-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2019-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2019-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-01-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2019-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-01-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2019-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-01-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2019-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION		2019-01-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2019-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207595-001	NALBUPHINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2019-01-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207595-002	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2019-01-11	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A207595-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207595-002	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A207595-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207595-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207595-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207595-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207595-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207595-002	AP	1	`ea99ee380514…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Hospira, Inc.	a99fe500-f52b-483c-807c-178f1a78a02b	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nalbuphine Hydrochloride generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Henry Schein, Inc.	dd621bfa-ce48-4c27-b247-a6d885f70b72	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nalbuphine Hydrochloride generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Henry Schein, Inc.	4ef2c0dc-3ab4-4bb1-aff0-523e3c23ad2d	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nalbuphine Hydrochloride generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Hospira, Inc.	6025e8d4-5083-4c3a-58a0-050e7b0b6150	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nalbuphine Hydrochloride generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	ProPharma Distribution	38569b5f-fb37-135e-e063-6294a90a54df	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nalbuphine Hydrochloride generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Henry Schein, Inc.	596826ff-e471-4d4f-9a73-2a34e2af2dd6	2025-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nalbuphine Hydrochloride generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine hydrochloride	NALBUPHINE HYDROCHLORIDE	Somerset Therapeutics, LLC	a3221c05-5822-4ab8-b589-0e3939b91a68	2025-03-26	Boxed warning, Adverse reactions	Name fallback brand name: Nalbuphine hydrochloride generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine hydrochloride	NALBUPHINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	292b0d0e-f222-d384-e063-6394a90acd44	2024-12-13	Boxed warning, Adverse reactions	Name fallback brand name: Nalbuphine hydrochloride generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	28f274a4-62c4-4e54-e063-6394a90a2200	2024-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nalbuphine Hydrochloride generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine hydrochloride	NALBUPHINE HYDROCHLORIDE	Somerset Therapeutics, LLC	d82dafac-cce7-445a-8127-2a10b6d947ca	2024-09-26	Boxed warning, Adverse reactions	Name fallback brand name: Nalbuphine hydrochloride generic name: NALBUPHINE HYDROCHLORIDE
Nalbuphine Hydrochloride	NALBUPHINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6bde2184-5643-3ec6-e053-2991aa0a115f	2023-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Nalbuphine Hydrochloride generic name: NALBUPHINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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