Application 200403

Type: NDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	INJECTABLE;INJECTION	1MG/ML	No	No
002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	INJECTABLE;INJECTION	2MG/ML	No	No
003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	INJECTABLE;INJECTION	4MG/ML	No	No
004	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	INJECTABLE;INJECTION	0.5MG/0.5ML	No	No
005	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	INJECTABLE;INJECTION	0.25MG/0.5ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
N200403-001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2011-12-01
N200403-002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2011-12-01
N200403-003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	2011-12-01
N200403-004	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		2022-06-13
N200403-005	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		2023-03-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N200403-001	AP
N200403-002	AP
N200403-003	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.

Product history page 1 of 5 · 174 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
2026-02-19 14:30 UTC	2026-02	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		2022-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		2023-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		2022-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		2023-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		2022-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		2023-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		2022-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		2023-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		2022-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		2023-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		2022-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		2023-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		2022-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		2023-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-001	HYDROMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-002	HYDROMORPHONE HYDROCHLORIDE	2MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-003	HYDROMORPHONE HYDROCHLORIDE	4MG/ML	INJECTABLE / INJECTION	AP	2011-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-004	HYDROMORPHONE HYDROCHLORIDE	0.5MG/0.5ML	INJECTABLE / INJECTION		2022-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-005	HYDROMORPHONE HYDROCHLORIDE	0.25MG/0.5ML	INJECTABLE / INJECTION		2023-03-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200403-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200403-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200403-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200403-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200403-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200403-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200403-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200403-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200403-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200403-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200403-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200403-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200403-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200403-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200403-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200403-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200403-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200403-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200403-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200403-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200403-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200403-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200403-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200403-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200403-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N200403-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200403-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200403-002	AP	1	`5c6f7cd8ea54…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	f9ca2ef5-46d8-475a-a26e-f7c8becd6db7	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200403 application number: NDA200403 ndc (product): 0409-1312 ndc (product): 0409-1283 ndc (product): 0409-4264
Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	e9c9ef18-7dfc-4322-b2fc-29b934c30f8b	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200403 application number: NDA200403 ndc (product): 0409-1312 ndc (product): 0409-1283 ndc (product): 0409-1304 ndc (product): 0409-2552 ndc (product): 0409-2540 ndc (product): 0409-3365 ndc (product): 0409-3356

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 62 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1304	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1304	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1304	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1304	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1304	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1304	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1304	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1304	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1304	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1312	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1312	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1312	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1312	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1312	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1312	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1312	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1312	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1312	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1312	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1312	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1312	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-2540	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-2540	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-2540	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-2540	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-2552	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-2552	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-2552	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-2552	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-2552	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-2552	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-2552	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-2552	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-2552	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3356	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3356	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3356	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3356	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3365	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3365	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3365	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3365	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3365	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3365	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3365	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3365	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3365	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-4264	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-4264	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84637	SUPPL	2026-01-05
84617	SUPPL	2025-12-31
77069	SUPPL	2023-12-19
76942	SUPPL	2023-12-18
60448	SUPPL	2019-10-09
60281	SUPPL	2019-10-07
46389	SUPPL	2016-12-21
46329	SUPPL	2016-12-20
9822	SUPPL	2015-07-20
40022	SUPPL	2015-07-17
44821	ORIG	2012-06-05
22831	ORIG	2012-06-05
9820	ORIG	2011-12-05
40021	ORIG	2011-12-02
9821	ORIG	2011-03-02