Application 200403
- Type
- NDA
- Sponsor
- HOSPIRA INC
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N200403-001 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 1MG/ML | INJECTABLE / INJECTION | AP | RLD | 2011-12-01 |
| N200403-002 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 2MG/ML | INJECTABLE / INJECTION | AP | RLD | 2011-12-01 |
| N200403-003 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 4MG/ML | INJECTABLE / INJECTION | AP | RLD | 2011-12-01 |
| N200403-004 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 0.5MG/0.5ML | INJECTABLE / INJECTION | RLD | 2022-06-13 | |
| N200403-005 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 0.25MG/0.5ML | INJECTABLE / INJECTION | RLD | 2023-03-03 |
Therapeutic equivalence codes#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N200403-001 | HYDROMORPHONE HYDROCHLORIDE | 1MG/ML | INJECTABLE / INJECTION | AP | RLD | 2011-12-01 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N200403-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG/ML | INJECTABLE / INJECTION | AP | RLD | 2011-12-01 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N200403-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG/ML | INJECTABLE / INJECTION | AP | RLD | 2011-12-01 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N200403-004 | HYDROMORPHONE HYDROCHLORIDE | 0.5MG/0.5ML | INJECTABLE / INJECTION | RLD | 2022-06-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200403-005 | HYDROMORPHONE HYDROCHLORIDE | 0.25MG/0.5ML | INJECTABLE / INJECTION | RLD | 2023-03-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N200403-001 | HYDROMORPHONE HYDROCHLORIDE | 1MG/ML | INJECTABLE / INJECTION | AP | 2011-12-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200403-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG/ML | INJECTABLE / INJECTION | AP | 2011-12-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200403-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG/ML | INJECTABLE / INJECTION | AP | 2011-12-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200403-004 | HYDROMORPHONE HYDROCHLORIDE | 0.5MG/0.5ML | INJECTABLE / INJECTION | 2022-06-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N200403-005 | HYDROMORPHONE HYDROCHLORIDE | 0.25MG/0.5ML | INJECTABLE / INJECTION | 2023-03-03 | caaa826d4ba7… | ||
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N200403-003 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N200403-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N200403-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N200403-003 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N200403-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N200403-002 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N200403-003 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N200403-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N200403-002 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N200403-003 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N200403-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N200403-002 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N200403-003 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N200403-001 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N200403-002 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N200403-003 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N200403-001 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N200403-002 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N200403-003 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N200403-001 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N200403-002 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N200403-003 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N200403-003 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N200403-003 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N200403-001 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N200403-002 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N200403-003 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N200403-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N200403-002 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N200403-003 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N200403-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N200403-002 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N200403-003 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N200403-001 | AP | 1 | 6a51e52b5d6a… |
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.
| 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 | 200403 NDA200403 0409-1312 0409-1283 0409-4264 |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Hospira, Inc. | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | 200403 NDA200403 0409-1312 0409-1283 0409-1304 0409-2552 0409-2540 0409-3365 0409-3356 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| 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 |
|---|---|---|
| 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 |