Home Applications 022402 Application 022402
Type NDA
Sponsor HIKMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CODEINE SULFATE CODEINE SULFATE TABLET;ORAL 15MG Yes No 002 CODEINE SULFATE CODEINE SULFATE TABLET;ORAL 30MG Yes No 003 CODEINE SULFATE CODEINE SULFATE TABLET;ORAL 60MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022402-001 CODEINE SULFATE CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 N022402-002 CODEINE SULFATE CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 N022402-003 CODEINE SULFATE CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 2026-02-19 14:30 UTC 2026-02 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022402-002 CODEINE SULFATE 30MG TABLET / ORAL AB RLD 2009-07-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022402-003 CODEINE SULFATE 60MG TABLET / ORAL AB RLD, RS 2009-07-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022402-001 CODEINE SULFATE 15MG TABLET / ORAL AB RLD 2009-07-16 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0054-0243 Codeine sulfate codeine sulfate West-Ward Pharmaceuticals Corp. NDA Current 0054-0243 Codeine sulfate codeine sulfate West-Ward Pharmaceuticals Corp. NDA Current 0054-0243 Codeine sulfate codeine sulfate West-Ward Pharmaceuticals Corp. NDA Current 0054-0244 Codeine sulfate codeine sulfate West-Ward Pharmaceuticals Corp. NDA Current 0054-0244 Codeine sulfate codeine sulfate West-Ward Pharmaceuticals Corp. NDA Current 0054-0244 Codeine sulfate codeine sulfate West-Ward Pharmaceuticals Corp. NDA Current 0054-0244 Codeine sulfate codeine sulfate West-Ward Pharmaceuticals Corp. NDA Current 0054-0245 Codeine sulfate codeine sulfate West-Ward Pharmaceuticals Corp. NDA Current 0054-0245 Codeine sulfate codeine sulfate West-Ward Pharmaceuticals Corp. NDA Current 0054-0245 Codeine sulfate codeine sulfate West-Ward Pharmaceuticals Corp. NDA Current 0054-0245 Codeine sulfate codeine sulfate West-Ward Pharmaceuticals Corp. NDA Current