Application 206735
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 5MG | No | No |
| 002 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG | No | No |
| 003 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 15MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206735-001 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | ||
| A206735-002 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | ||
| A206735-003 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A206735-001 | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206735-002 | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206735-003 | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206735-001 | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206735-002 | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206735-003 | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206735-001 | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206735-002 | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206735-003 | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206735-001 | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206735-002 | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206735-003 | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206735-001 | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206735-002 | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206735-003 | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206735-001 | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206735-002 | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206735-003 | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206735-001 | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206735-002 | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206735-003 | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206735-001 | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206735-002 | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206735-003 | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206735-001 | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206735-002 | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206735-003 | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206735-001 | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206735-002 | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206735-003 | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206735-001 | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206735-002 | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206735-003 | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206735-001 | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206735-002 | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206735-003 | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206735-001 | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206735-002 | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206735-003 | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206735-001 | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-01-27 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | A206735-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A206735-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A206735-003 | AB | 1 | ea99ee380514… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | SUNRISE PHARMACEUTICAL, INC. | 93b3a40f-b7ac-4047-8ff5-3e34c2d75193 | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE |
| dextroamphetamine sulfate | DEXTROAMPHETAMINE SULFATE | Actavis Pharma, Inc. | 9e92ccc3-d81c-461d-a19f-7e9b582be357 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | dextroamphetamine sulfate DEXTROAMPHETAMINE SULFATE |
| Dextroamphetamine Sulfate Extended-Release | DEXTROAMPHETAMINE SULFATE | SpecGx LLC | 69c40af8-3710-46bf-bd3d-137fe5eea23e | 2025-12-08 | Boxed warning, Warnings, Adverse reactions | DEXTROAMPHETAMINE SULFATE |
| Zenzedi | DEXTROAMPHETAMINE SULFATE | Azurity Pharmaceuticals, Inc. | d6394df5-f2c9-47eb-b57e-f3e9cfd94f84 | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | DEXTROAMPHETAMINE SULFATE |
| DEXEDRINE SPANSULE | DEXTROAMPHETAMINE SULFATE | Amneal Pharmaceuticals LLC | cc717b9b-22ea-4c60-a1d4-ee38a40bce78 | 2025-09-25 | Boxed warning, Warnings, Adverse reactions | DEXTROAMPHETAMINE SULFATE |
| Dextroamphetamine Sulfate | DEXTROAMPHETAMINE SULFATE | Bryant Ranch Prepack | 9346ff55-b751-4919-ae63-eb58b69e3f0f | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | Dextroamphetamine Sulfate DEXTROAMPHETAMINE SULFATE |
| Dextroamphetamine Sulfate | DEXTROAMPHETAMINE SULFATE | Bryant Ranch Prepack | 54b122b0-2ec8-43c9-86e8-a3538a83c776 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | Dextroamphetamine Sulfate DEXTROAMPHETAMINE SULFATE |
| Dextroamphetamine Sulfate | DEXTROAMPHETAMINE SULFATE | Bryant Ranch Prepack | 9f1c9cb0-7752-40cc-8ed1-5e79b8dc9da2 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | Dextroamphetamine Sulfate DEXTROAMPHETAMINE SULFATE |
| Dextroamphetamine Sulfate | DEXTROAMPHETAMINE SULFATE | Bryant Ranch Prepack | fc164327-dd48-4851-b613-71d957ee6066 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | Dextroamphetamine Sulfate DEXTROAMPHETAMINE SULFATE |
| Dextroamphetamine Sulfate | DEXTROAMPHETAMINE SULFATE | Bryant Ranch Prepack | b40c9a90-7e2e-48d6-adb6-2351c0ca621d | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | Dextroamphetamine Sulfate DEXTROAMPHETAMINE SULFATE |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | SpecGx LLC | e05cf690-d45a-4696-a1bf-40c9350cc084 | 2025-07-07 | Boxed warning, Warnings, Adverse reactions | DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE |
| Dextroamphetamine Sulfate | DEXTROAMPHETAMINE SULFATE | Winder Laboratories LLC | ca1a8890-0675-4c9c-9716-6c28f975d827 | 2025-06-18 | Boxed warning, Warnings, Adverse reactions | Dextroamphetamine Sulfate DEXTROAMPHETAMINE SULFATE |
| Dextroamphetamine Sulfate | DEXTROAMPHETAMINE SULFATE | Wilshire Pharmaceuticals, Inc. | 6b8c97ac-c83c-4a1f-a33c-121239253abf | 2025-06-13 | Boxed warning, Warnings, Adverse reactions | Dextroamphetamine Sulfate DEXTROAMPHETAMINE SULFATE |
| Dextroamphetamine Sulfate | DEXTROAMPHETAMINE SULFATE | Teva Pharmaceuticals USA, Inc. | ec2d13f3-d14f-47e4-abe9-7763f95a8e94 | 2025-05-21 | Boxed warning, Warnings, Adverse reactions | Dextroamphetamine Sulfate DEXTROAMPHETAMINE SULFATE |
| Dextroamphetamine Sulfate | DEXTROAMPHETAMINE SULFATE | Cranbury Pharmaceuticals, LLC | 9acdf000-fefe-47c7-a44c-0f7a65c5c05c | 2025-05-19 | Boxed warning, Warnings, Adverse reactions | Dextroamphetamine Sulfate DEXTROAMPHETAMINE SULFATE |
| PROCENTRA | DEXTROAMPHETAMINE SULFATE | INDEPENDENCE PHARMACEUTICALS, LLC | 1548cce2-fb6b-4f17-8a3b-868933f6c9d6 | 2025-05-14 | Boxed warning, Warnings, Adverse reactions | DEXTROAMPHETAMINE SULFATE |
| Dextroamphetamine Sulfate | DEXTROAMPHETAMINE SULFATE | Prasco Laboratories | 94674695-aa8a-3150-e053-2995a90a445f | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | Dextroamphetamine Sulfate DEXTROAMPHETAMINE SULFATE |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | Bryant Ranch Prepack | 466cbae8-4f67-4a65-b670-ada6a953d550 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | Bryant Ranch Prepack | 0ef920a9-c5b9-4d31-a478-ee18d22a3c5b | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | Bryant Ranch Prepack | c706a849-9df6-43ca-9ac6-1d9ce6b8e855 | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1070 | Dextroamphetamine Sulfate | Dextroamphetamine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1071 | Dextroamphetamine Sulfate | Dextroamphetamine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1072 | Dextroamphetamine Sulfate | Dextroamphetamine | Mylan Pharmaceuticals Inc. | ANDA | Current |