Home Applications 202515 Application 202515
Type NDA
Sponsor HOSPIRA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 2MG/ML Yes Yes 002 MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 4MG/ML Yes Yes 003 MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 8MG/ML Yes Yes 004 MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 10MG/ML Yes Yes 005 MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 15MG/ML Yes No 006 MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 50MG/ML Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202515-001 MORPHINE SULFATE MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 N202515-002 MORPHINE SULFATE MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 N202515-003 MORPHINE SULFATE MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 N202515-004 MORPHINE SULFATE MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 N202515-005 MORPHINE SULFATE MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 N202515-006 MORPHINE SULFATE MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD, RS 2021-04-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 7 · 256 observed 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 2026-10-15 13:18:30 2026-09 N202515-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202515-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202515-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202515-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202515-005 MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202515-006 MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD, RS 2021-04-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 N202515-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202515-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202515-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202515-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202515-005 MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202515-006 MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD, RS 2021-04-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202515-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202515-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202515-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202515-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202515-005 MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202515-006 MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD, RS 2021-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202515-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202515-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202515-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202515-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202515-005 MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202515-006 MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD, RS 2021-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202515-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202515-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202515-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202515-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202515-005 MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202515-006 MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD, RS 2021-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202515-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202515-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202515-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202515-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202515-005 MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202515-006 MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD, RS 2021-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202515-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202515-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202515-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202515-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 152 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 35 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0409-1890 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1890 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1890 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1890 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1890 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1890 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1890 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1890 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1890 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1890 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1890 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1891 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1891 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1891 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1891 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1891 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1891 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1891 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1891 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1891 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1892 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1892 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1892 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1892 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1892 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1892 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1893 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1893 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1893 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1893 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1893 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1893 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1893 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1893 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current 0409-1893 Morphine Sulfate MORPHINE SULFATE Hospira, Inc. NDA Current