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DEXTROAMPHETAMINE SULFATE 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 A083563-002 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE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SULFATE 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 A083563-003 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE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DEXTROAMPHETAMINE SULFATE 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 A083563-004 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE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SULFATE 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982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 4 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 2024-02-18 07:12 UTC 2024-02 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A083563-001 DELCOBESE 5MG;5MG;5MG;5MG TABLET / ORAL Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A083563-002 DELCOBESE 3.75MG;3.75MG;3.75MG;3.75MG TABLET / ORAL Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A083563-003 DELCOBESE 2.5MG;2.5MG;2.5MG;2.5MG TABLET / ORAL Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A083563-004 DELCOBESE 1.25MG;1.25MG;1.25MG;1.25MG TABLET / ORAL Approved before 1982 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.