FDA.reportPublic FDA data

Application 209253

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPHETAMINEAMPHETAMINETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALEQ 3.1MG BASENoNo
002AMPHETAMINEAMPHETAMINETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALEQ 6.3MG BASENoNo
003AMPHETAMINEAMPHETAMINETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALEQ 9.4MG BASENoNo
004AMPHETAMINEAMPHETAMINETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALEQ 12.5MG BASENoNo
005AMPHETAMINEAMPHETAMINETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALEQ 15.7MG BASENoNo
006AMPHETAMINEAMPHETAMINETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORALEQ 18.8MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A209253-001AMPHETAMINEAMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22
A209253-002AMPHETAMINEAMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22
A209253-003AMPHETAMINEAMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22
A209253-004AMPHETAMINEAMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22
A209253-005AMPHETAMINEAMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22
A209253-006AMPHETAMINEAMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A209253-001AB
A209253-002AB
A209253-003AB
A209253-004AB
A209253-005AB
A209253-006AB

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 2 of 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209253-005AMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209253-006AMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209253-001AMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209253-002AMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209253-003AMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209253-004AMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209253-005AMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209253-006AMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209253-001AMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209253-002AMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209253-003AMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209253-004AMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209253-005AMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209253-006AMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209253-001AMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209253-002AMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209253-003AMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209253-004AMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209253-005AMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209253-006AMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209253-001AMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209253-002AMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209253-003AMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209253-004AMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209253-005AMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209253-006AMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209253-001AMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209253-002AMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209253-003AMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209253-004AMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209253-005AMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209253-006AMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209253-001AMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A209253-002AMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A209253-003AMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A209253-004AMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A209253-005AMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A209253-006AMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209253-001AMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209253-002AMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-2279d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A209253-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A209253-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A209253-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A209253-004AB1c2088c7a36db…
2026-10-15 13:18:302026-09A209253-005AB1c2088c7a36db…
2026-10-15 13:18:302026-09A209253-006AB1c2088c7a36db…
2026-09-14 22:38:342026-08A209253-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A209253-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A209253-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A209253-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A209253-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A209253-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A209253-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209253-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209253-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209253-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209253-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209253-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209253-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209253-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-006AB16a471c1ec25d…
2023-12-20 04:57 UTC2023-12A209253-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209253-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209253-003AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209253-004AB1ea1830bbd6c7…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmphetamineAMPHETAMINETeva Pharmaceuticals, Inc.243e88e7-6621-47e9-8d5c-3f79bcb088bb2025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209253
application number: ANDA209253

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74729ORIG 2023-07-13