Home Applications 203046 Application 203046
Type ANDA
Sponsor LANNETT CO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CODEINE SULFATE CODEINE SULFATE TABLET;ORAL 15MG No No 002 CODEINE SULFATE CODEINE SULFATE TABLET;ORAL 30MG No No 003 CODEINE SULFATE CODEINE SULFATE TABLET;ORAL 60MG No No
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 A203046-001 CODEINE SULFATE CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 A203046-002 CODEINE SULFATE CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 A203046-003 CODEINE SULFATE CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13
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 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203046-002 CODEINE SULFATE 30MG TABLET / ORAL AB 2014-06-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203046-003 CODEINE SULFATE 60MG TABLET / ORAL AB 2014-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203046-001 CODEINE SULFATE 15MG TABLET / ORAL AB 2014-06-13 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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0527-1698 Codeine Sulfate Codeine Sulfate Lannett Company, Inc. ANDA Current 0527-1698 Codeine Sulfate Codeine Sulfate Lannett Company, Inc. ANDA Current 0527-1698 Codeine Sulfate Codeine Sulfate Lannett Company, Inc. ANDA Current 0527-1698 Codeine Sulfate Codeine Sulfate Lannett Company, Inc. ANDA Current 0527-1699 Codeine Sulfate Codeine Sulfate Lannett Company, Inc. ANDA Current 0527-1699 Codeine Sulfate Codeine Sulfate Lannett Company, Inc. ANDA Current 0527-1699 Codeine Sulfate Codeine Sulfate Lannett Company, Inc. ANDA Current 0527-1699 Codeine Sulfate Codeine Sulfate Lannett Company, Inc. ANDA Current 0527-1727 Codeine Sulfate Codeine Sulfate Lannett Company, Inc. ANDA Current 0527-1727 Codeine Sulfate Codeine Sulfate Lannett Company, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 76089 ORIG 2023-11-02