Application 206340

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL1.25MG;1.25MG;1.25MG;1.25MGNoNo
002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL1.875MG;1.875MG;1.875MG;1.875MGNoNo
003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL2.5MG;2.5MG;2.5MG;2.5MGNoNo
004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL3.125MG;3.125MG;3.125MG;3.125MGNoNo
005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL3.75MG;3.75MG;3.75MG;3.75MGNoNo
006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL5MG;5MG;5MG;5MGNoNo
007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATETABLET;ORAL7.5MG;7.5MG;7.5MG;7.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206340-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2016-02-05
A206340-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2016-02-05
A206340-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2016-02-05
A206340-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2016-02-05
A206340-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2016-02-05
A206340-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2016-02-05
A206340-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2016-02-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A206340-001AB
A206340-002AB
A206340-003AB
A206340-004AB
A206340-005AB
A206340-006AB
A206340-007AB

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 8 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206340-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2016-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206340-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2016-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206340-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2016-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206340-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2016-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206340-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2016-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206340-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2016-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206340-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2016-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206340-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2016-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206340-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2016-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206340-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2016-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206340-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2016-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206340-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2016-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206340-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2016-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206340-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2016-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A206340-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2016-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206340-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2016-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206340-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2016-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206340-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2016-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206340-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2016-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206340-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2016-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206340-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2016-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206340-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2016-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206340-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2016-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206340-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2016-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206340-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2016-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206340-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2016-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206340-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2016-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206340-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2016-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206340-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2016-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206340-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2016-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206340-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2016-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206340-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2016-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206340-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2016-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206340-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2016-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206340-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2016-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206340-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2016-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206340-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2016-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206340-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2016-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206340-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2016-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206340-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2016-02-0503ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206340-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206340-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206340-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206340-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206340-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206340-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206340-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206340-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206340-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206340-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206340-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206340-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206340-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206340-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206340-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206340-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206340-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206340-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206340-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206340-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206340-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206340-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206340-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206340-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206340-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206340-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206340-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206340-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206340-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206340-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206340-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206340-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206340-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206340-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206340-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206340-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206340-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206340-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206340-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206340-005AB103ed91905a0d…