Application 075559

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUTORPHANOL TARTRATE	BUTORPHANOL TARTRATE	INJECTABLE;INJECTION	1MG/ML	No	No
002	BUTORPHANOL TARTRATE	BUTORPHANOL TARTRATE	INJECTABLE;INJECTION	2MG/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
A075559-001	BUTORPHANOL TARTRATE	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION			2000-03-20
A075559-002	BUTORPHANOL TARTRATE	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION			2000-03-20

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075559-001	BUTORPHANOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	2000-03-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075559-002	BUTORPHANOL TARTRATE	2MG/ML	INJECTABLE / INJECTION	2000-03-20	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butorphanol Tartrate	BUTORPHANOL TARTRATE	Bryant Ranch Prepack	412499ce-db93-4943-ae1a-564c27b1fb16	2026-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butorphanol Tartrate generic name: BUTORPHANOL TARTRATE
Butorphanol Tartrate	BUTORPHANOL TARTRATE	Hospira, Inc.	9822ca3f-aee2-46e5-8a96-495400e65d10	2026-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butorphanol Tartrate generic name: BUTORPHANOL TARTRATE
Butorphanol Tartrate	BUTORPHANOL TARTRATE	Apotex Corp.	b8e48063-0b40-ee43-85c1-4ef2de80c404	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butorphanol Tartrate generic name: BUTORPHANOL TARTRATE
Butorphanol Tartrate	BUTORPHANOL TARTRATE	Hikma Pharmaceuticals USA Inc.	5a50d22e-acbe-4b15-9ed6-70713378408a	2025-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butorphanol Tartrate generic name: BUTORPHANOL TARTRATE
Butorphanol Tartrate	BUTORPHANOL TARTRATE	Hikma Pharmaceuticals USA Inc.	bded5531-8847-4576-9a29-3e44f979d2e0	2024-04-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Butorphanol Tartrate generic name: BUTORPHANOL TARTRATE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8716	ORIG	2000-03-20