Application 217787

Type
ANDA
Sponsor
ALKEM LABS LTD

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 43.

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
A217787-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2023-10-06
A217787-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2023-10-06
A217787-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2023-10-06
A217787-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2023-10-06
A217787-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2023-10-06
A217787-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2023-10-06
A217787-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2023-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217787-001AB
A217787-002AB
A217787-003AB
A217787-004AB
A217787-005AB
A217787-006AB
A217787-007AB

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 4 · 154 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217787-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2023-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A217787-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2023-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A217787-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2023-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A217787-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2023-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A217787-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2023-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A217787-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2023-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A217787-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2023-10-0684e616aacf4f…
2026-08-18 06:07:402026-07A217787-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2023-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A217787-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2023-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A217787-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2023-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A217787-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2023-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A217787-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2023-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A217787-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2023-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A217787-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2023-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217787-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2023-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217787-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2023-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217787-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2023-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217787-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2023-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217787-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2023-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217787-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2023-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217787-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2023-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217787-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2023-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217787-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2023-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217787-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2023-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217787-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2023-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217787-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2023-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217787-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2023-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217787-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2023-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A217787-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2023-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217787-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2023-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217787-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2023-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217787-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2023-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217787-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2023-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217787-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGTABLET / ORALAB2023-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217787-007DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGTABLET / ORALAB2023-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217787-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGTABLET / ORALAB2023-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217787-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.875MG;1.875MG;1.875MG;1.875MGTABLET / ORALAB2023-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217787-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGTABLET / ORALAB2023-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217787-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.125MG;3.125MG;3.125MG;3.125MGTABLET / ORALAB2023-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217787-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGTABLET / ORALAB2023-10-06fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 154 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-02-18 07:12 UTC2024-02A217787-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217787-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217787-004AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217787-005AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217787-006AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217787-007AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217787-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217787-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217787-003AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217787-004AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217787-005AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217787-006AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217787-007AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217787-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217787-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217787-003AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217787-004AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217787-005AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217787-006AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217787-007AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217787-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217787-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217787-003AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217787-004AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217787-005AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217787-006AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217787-007AB19b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217787-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217787-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217787-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217787-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217787-005AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217787-006AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217787-007AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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