Application 212186
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | TABLET;ORAL | 5MG | No | No |
| 002 | AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212186-001 | AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | ||
| A212186-002 | AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 |
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 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | 2021-01-27 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | 2021-01-27 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212186-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2021-01-27 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212186-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2021-01-27 | 87673890dc5c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212186-001 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212186-002 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A212186-001 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A212186-002 | AA | 1 | 5aa47cf7b7d7… |
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 |
|---|---|---|---|---|---|---|
| Amphetamine Sulfate | AMPHETAMINE SULFATE | Amici Pharma, Inc. | e045dc28-e05d-4407-9d44-d0a11ca558e6 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | Amphetamine Sulfate AMPHETAMINE SULFATE |
| Amphetamine Sulfate | AMPHETAMINE SULFATE | Granules Pharmaceuticals Inc. | 26dbad66-13c4-4906-88b3-ab7ee191466c | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | Amphetamine Sulfate AMPHETAMINE SULFATE |
| Amphetamine Sulfate | AMPHETAMINE SULFATE | Bryant Ranch Prepack | b94e2562-fd19-455f-ac10-2cc24302d27a | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | Amphetamine Sulfate AMPHETAMINE SULFATE |
| Amphetamine Sulfate | AMPHETAMINE SULFATE | Bryant Ranch Prepack | 920f99f4-ab78-4eed-9d80-08a2ebd0b769 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | Amphetamine Sulfate AMPHETAMINE SULFATE |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Bryant Ranch Prepack | 9817a519-fdb0-474a-92f4-2e485c9cb047 | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | AMPHETAMINE SULFATE AMPHETAMINE SULFATE |
| Amphetamine Sulfate | AMPHETAMINE SULFATE | Epic Pharma LLC | 432db708-91b7-4802-88c3-ceef597b91da | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | Amphetamine Sulfate AMPHETAMINE SULFATE |
| Amphetamine Sulfate | AMPHETAMINE SULFATE | Wilshire Pharmaceuticals, Inc. | 91add2e3-8359-47dc-b79f-197d36b02819 | 2025-10-24 | Boxed warning, Warnings, Adverse reactions | Amphetamine Sulfate AMPHETAMINE SULFATE |
| Evekeo | AMPHETAMINE SULFATE | Azurity Pharmaceuticals, Inc. | f469fb38-0380-4621-9db3-a4f429126156 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | AMPHETAMINE SULFATE |
| Amphetamine Sulfate | AMPHETAMINE | Amneal Pharmaceuticals NY LLC | 53d40847-e0d3-48ec-81a7-ec5478553565 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | Amphetamine Sulfate |
| Amphetamine Sulfate | AMPHETAMINE SULFATE | Bryant Ranch Prepack | 674940ec-1714-4e41-b471-2a8c8a6c5ade | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | Amphetamine Sulfate AMPHETAMINE SULFATE |
| Amphetamine Sulfate | AMPHETAMINE SULFATE | Bryant Ranch Prepack | c972a6a4-a96c-4d70-b4c4-eef9e990abb4 | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | Amphetamine Sulfate AMPHETAMINE SULFATE |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Solco Healthcare US, LLC | 89c5b52f-3c2a-41d5-8624-9ee51c512c72 | 2025-05-15 | Boxed warning, Warnings, Adverse reactions | AMPHETAMINE SULFATE AMPHETAMINE SULFATE |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Bryant Ranch Prepack | 9eb84b3c-2147-42dd-8053-6afd1a88b0c1 | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | AMPHETAMINE SULFATE AMPHETAMINE SULFATE |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Bryant Ranch Prepack | 3ad894e3-78a7-4e3b-80d1-1a925fb6d9e3 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | AMPHETAMINE SULFATE AMPHETAMINE SULFATE |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Bryant Ranch Prepack | 698171ee-4328-476a-b71c-58aa6dc93b23 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | AMPHETAMINE SULFATE AMPHETAMINE SULFATE |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Bryant Ranch Prepack | c00bbade-3dc8-422b-8cff-f85db408bdfc | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | AMPHETAMINE SULFATE AMPHETAMINE SULFATE |
| Amphetamine Sulfate | AMPHETAMINE SULFATE | Aurolife Pharma, LLC | 20735c2e-6304-425f-a4e4-584f6f90d6a0 | 2024-01-29 | Boxed warning, Warnings, Adverse reactions | Amphetamine Sulfate AMPHETAMINE SULFATE |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Bryant Ranch Prepack | ad4ce013-331b-4359-898f-bac97d64874f | 2024-01-25 | Boxed warning, Warnings, Adverse reactions | AMPHETAMINE SULFATE AMPHETAMINE SULFATE |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Bryant Ranch Prepack | 7f16dd18-bf30-41ef-8981-932da5df0951 | 2024-01-25 | Boxed warning, Warnings, Adverse reactions | AMPHETAMINE SULFATE AMPHETAMINE SULFATE |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Lannett Company, Inc. | 85a015a7-a1a0-4b04-8bc4-7aacd0c84742 | 2024-01-19 | Boxed warning, Warnings, Adverse reactions | AMPHETAMINE SULFATE AMPHETAMINE SULFATE |