FDA.reportPublic FDA data

Application 083563

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DELCOBESEAMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL5MG;5MG;5MG;5MGNoNo
002DELCOBESEAMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL3.75MG;3.75MG;3.75MG;3.75MGNoNo
003DELCOBESEAMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL2.5MG;2.5MG;2.5MG;2.5MGNoNo
004DELCOBESEAMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL1.25MG;1.25MG;1.25MG;1.25MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A083563-001DELCOBESEAMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982
A083563-002DELCOBESEAMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982
A083563-003DELCOBESEAMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982
A083563-004DELCOBESEAMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982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 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A083563-001DELCOBESE5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08A083563-002DELCOBESE3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08A083563-003DELCOBESE2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08A083563-004DELCOBESE1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07A083563-001DELCOBESE5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A083563-002DELCOBESE3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A083563-003DELCOBESE2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A083563-004DELCOBESE1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A083563-001DELCOBESE5MG;5MG;5MG;5MGTABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083563-002DELCOBESE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083563-003DELCOBESE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083563-004DELCOBESE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083563-001DELCOBESE5MG;5MG;5MG;5MGTABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083563-002DELCOBESE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083563-003DELCOBESE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083563-004DELCOBESE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A083563-001DELCOBESE5MG;5MG;5MG;5MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083563-002DELCOBESE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083563-003DELCOBESE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083563-004DELCOBESE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083563-001DELCOBESE5MG;5MG;5MG;5MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083563-002DELCOBESE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083563-003DELCOBESE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083563-004DELCOBESE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083563-001DELCOBESE5MG;5MG;5MG;5MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083563-002DELCOBESE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083563-003DELCOBESE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083563-004DELCOBESE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083563-001DELCOBESE5MG;5MG;5MG;5MGTABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083563-002DELCOBESE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083563-003DELCOBESE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083563-004DELCOBESE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083563-001DELCOBESE5MG;5MG;5MG;5MGTABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083563-002DELCOBESE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083563-003DELCOBESE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083563-004DELCOBESE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083563-001DELCOBESE5MG;5MG;5MG;5MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083563-002DELCOBESE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083563-003DELCOBESE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083563-004DELCOBESE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALApproved before 19825bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.