Application 077488
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 1.25MG;1.25MG;1.25MG;1.25MG | No | No |
| 002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 2.5MG;2.5MG;2.5MG;2.5MG | No | No |
| 003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 3.75MG;3.75MG;3.75MG;3.75MG | No | No |
| 004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 5MG;5MG;5MG;5MG | No | No |
| 005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 6.25MG;6.25MG;6.25MG;6.25MG | No | No |
| 006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 7.5MG;7.5MG;7.5MG;7.5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077488-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | ||
| A077488-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | ||
| A077488-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | ||
| A077488-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | ||
| A077488-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | ||
| A077488-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A077488-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077488-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077488-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077488-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077488-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077488-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A077488-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A077488-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A077488-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A077488-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A077488-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A077488-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077488-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077488-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077488-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077488-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077488-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077488-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A077488-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A077488-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A077488-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A077488-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A077488-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A077488-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-04-29 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A077488-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077488-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077488-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077488-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077488-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077488-006 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A077488-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077488-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077488-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077488-004 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077488-005 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077488-006 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077488-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077488-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077488-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077488-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077488-005 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077488-006 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077488-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077488-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077488-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077488-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077488-005 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077488-006 | AB | 1 | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.