Home Applications 083563 Application 083563
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 TABLET;ORAL 5MG;5MG;5MG;5MG No No 002 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 3.75MG;3.75MG;3.75MG;3.75MG No No 003 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG No No 004 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG 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 A083563-001 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DEXTROAMPHETAMINE SULFATE 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 A083563-002 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE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SULFATE 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 A083563-003 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE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DEXTROAMPHETAMINE SULFATE 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 A083563-004 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE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SULFATE 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982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 3 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 2022-03-09 01:35 UTC 2022-03 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 6a51e52b5d6a…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.