Home Applications 005378 Application 005378
Type NDA
Sponsor RECORDATI RARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 DESOXYN METHAMPHETAMINE HYDROCHLORIDE TABLET;ORAL 5MG Yes Yes 003 DESOXYN METHAMPHETAMINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG No No 004 DESOXYN METHAMPHETAMINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG No No 005 DESOXYN METHAMPHETAMINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N005378-002 DESOXYN METHAMPHETAMINE HYDROCHLORIDE 5MG TABLET / ORAL AA RLD, RS, Approved before 1982 N005378-003 DESOXYN METHAMPHETAMINE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982 N005378-004 DESOXYN METHAMPHETAMINE HYDROCHLORIDE 5MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982 N005378-005 DESOXYN METHAMPHETAMINE HYDROCHLORIDE 15MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N005378-002 AA
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 5 of 5 · 176 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 2022-10-28 04:53 UTC 2022-10 N005378-002 DESOXYN 5MG TABLET / ORAL AA RLD, RS, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N005378-003 DESOXYN 10MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N005378-004 DESOXYN 5MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N005378-005 DESOXYN 15MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N005378-002 DESOXYN 5MG TABLET / ORAL AA RLD, RS, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N005378-003 DESOXYN 10MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N005378-004 DESOXYN 5MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N005378-005 DESOXYN 15MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N005378-002 DESOXYN 5MG TABLET / ORAL AA RLD, RS, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N005378-003 DESOXYN 10MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N005378-004 DESOXYN 5MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N005378-005 DESOXYN 15MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N005378-002 DESOXYN 5MG TABLET / ORAL AA RLD, RS, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N005378-003 DESOXYN 10MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N005378-004 DESOXYN 5MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N005378-005 DESOXYN 15MG TABLET, EXTENDED RELEASE / ORAL Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 · 3 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55292-104 Desoxyn methamphetamine hydrochloride Recordati Rare Diseases Inc. NDA Current 55292-104 Desoxyn methamphetamine hydrochloride RECORDATI RARE DISEASES, INC. NDA Current 55292-104 Desoxyn methamphetamine hydrochloride RECORDATI RARE DISEASES, INC. NDA Current 55292-104 Desoxyn methamphetamine hydrochloride Recordati Rare Diseases, Inc. NDA Current 55292-104 Desoxyn methamphetamine hydrochloride RECORDATI RARE DISEASES, INC. NDA Current 70868-820 Desoxyn methamphetamine hydrochloride Key Therapeutics NDA Current