Home Applications 083564 Application 083564
Type ANDA
Sponsor TEVA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE CAPSULE;ORAL 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 002 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE CAPSULE;ORAL 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 003 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE CAPSULE;ORAL 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 004 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE CAPSULE;ORAL 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A083564-001 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 A083564-002 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 A083564-003 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 A083564-004 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982
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 · 172 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 2022-09-29 23:25 UTC 2022-09 A083564-001 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 A083564-002 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 A083564-003 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 A083564-004 DELCOBESE 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A083564-001 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A083564-002 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A083564-003 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A083564-004 DELCOBESE 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A083564-001 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A083564-002 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A083564-003 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A083564-004 DELCOBESE 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL Approved before 1982 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 22654 ORIG 2003-08-04