Home Applications 022207 Application 022207
Type NDA
Sponsor HIKMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MORPHINE SULFATE MORPHINE SULFATE TABLET;ORAL 15MG Yes No 002 MORPHINE SULFATE MORPHINE SULFATE TABLET;ORAL 30MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N022207-001 MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 N022207-002 MORPHINE SULFATE MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 84 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 2026-08-18 06:07:40 2026-07 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022207-001 MORPHINE SULFATE 15MG TABLET / ORAL AB RLD 2008-03-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022207-002 MORPHINE SULFATE 30MG TABLET / ORAL AB RLD, RS 2008-03-17 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 25 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0054-0235 Morphine Sulfate Morphine Sulfate Hikma Pharmaceuticals USA Inc. NDA Current 0054-0235 Morphine Sulfate Morphine Sulfate West-Ward Pharmaceuticals Corp NDA Current 0054-0235 Morphine Sulfate Morphine Sulfate West-Ward Pharmaceuticals Corp NDA Current 0054-0236 Morphine Sulfate Morphine Sulfate Hikma Pharmaceuticals USA Inc. NDA Current 0054-0236 Morphine Sulfate Morphine Sulfate West-Ward Pharmaceuticals Corp NDA Current 0054-0236 Morphine Sulfate Morphine Sulfate West-Ward Pharmaceuticals Corp NDA Current 49999-848 Morphine Sulfate Morphine Sulfate Lake Erie Medical DBA Quality Care Products LLC NDA Current 49999-848 Morphine Sulfate Morphine Sulfate Lake Erie Medical DBA Quality Care Products LLC NDA Current 49999-848 Morphine Sulfate Morphine Sulfate Lake Erie Medical DBA Quality Care Products LLC NDA Current 49999-848 Morphine Sulfate Morphine Sulfate Lake Erie Medical DBA Quality Care Products LLC NDA Current 49999-848 Morphine Sulfate Morphine Sulfate Lake Erie Medical DBA Quality Care Products LLC NDA Current 49999-848 Morphine Sulfate Morphine Sulfate Lake Erie Medical DBA Quality Care Products LLC NDA Current 49999-848 Morphine Sulfate Morphine Sulfate Lake Erie Medical DBA Quality Care Products LLC NDA Current 61919-413 MORPHINE SULFATE MORPHINE SULFATE DIRECTRX NDA Current 63629-3789 Morphine Sulfate Morphine Sulfate Bryant Ranch Prepack NDA Current 63629-3789 Morphine Sulfate Morphine Sulfate Bryant Ranch Prepack NDA Current 63629-3789 Morphine Sulfate Morphine Sulfate Bryant Ranch Prepack NDA Current 63629-3789 Morphine Sulfate Morphine Sulfate Bryant Ranch Prepack NDA Current 63629-4175 Morphine Sulfate Morphine Sulfate Bryant Ranch Prepack NDA Current 63629-4175 Morphine Sulfate Morphine Sulfate Bryant Ranch Prepack NDA Current 63629-4175 Morphine Sulfate Morphine Sulfate Bryant Ranch Prepack NDA Current 66336-502 Morphine Sulfate Morphine Sulfate Dispensing Solutions, Inc. NDA Current 67296-1522 Morphine Sulfate Morphine Sulfate RedPharm Drug, Inc. NDA Current 67296-1522 Morphine Sulfate Morphine Sulfate RedPharm Drug, Inc. NDA Current 67296-1522 Morphine Sulfate Morphine Sulfate RedPharm Drug, Inc. NDA Current