FDA.reportPublic FDA data

Application 211876

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL1.25MG;1.25MG;1.25MG;1.25MGNoNo
002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL2.5MG;2.5MG;2.5MG;2.5MGNoNo
003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL3.75MG;3.75MG;3.75MG;3.75MGNoNo
004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL5MG;5MG;5MG;5MGNoNo
005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL6.25MG;6.25MG;6.25MG;6.25MGNoNo
006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATECAPSULE, EXTENDED RELEASE;ORAL7.5MG;7.5MG;7.5MG;7.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211876-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24
A211876-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24
A211876-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24
A211876-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24
A211876-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24
A211876-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE7.5MG;7.5MG;7.5MG;7.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24

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 6 · 234 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211876-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-2484e616aacf4f…
2026-09-14 22:38:342026-08A211876-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-2484e616aacf4f…
2026-09-14 22:38:342026-08A211876-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-2484e616aacf4f…
2026-09-14 22:38:342026-08A211876-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-2484e616aacf4f…
2026-09-14 22:38:342026-08A211876-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-2484e616aacf4f…
2026-09-14 22:38:342026-08A211876-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-2484e616aacf4f…
2026-08-18 06:07:402026-07A211876-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07A211876-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07A211876-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07A211876-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07A211876-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07A211876-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211876-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211876-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211876-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211876-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211876-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211876-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211876-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211876-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211876-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211876-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211876-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211876-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211876-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211876-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211876-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211876-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211876-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211876-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211876-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211876-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211876-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211876-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211876-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211876-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211876-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211876-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211876-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211876-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORAL2020-06-24b8a1b40f171c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-12-22 03:56 UTC2020-12A211876-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A211876-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A211876-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A211876-004AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A211876-005AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A211876-006AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211876-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A211876-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A211876-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A211876-004AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A211876-005AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A211876-006AB1c0c555d07b60…

Reported adverse events (FAERS/openFDA)#

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