Application 215664
- Type
- ANDA
- Sponsor
- OSMOTICA PHARM US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 002 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
| 003 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 400MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215664-001 | CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 | ||
| A215664-002 | CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 | ||
| A215664-003 | CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 |
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 | A215664-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215664-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215664-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215664-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215664-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215664-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215664-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215664-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215664-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215664-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215664-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215664-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215664-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215664-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215664-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215664-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215664-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215664-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215664-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215664-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215664-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | 2680178bc6a6… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215664-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215664-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215664-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2024-10-22 | d8e5a09893c0… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215664-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215664-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215664-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-22 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215664-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215664-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215664-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215664-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215664-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215664-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215664-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215664-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215664-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215664-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215664-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215664-003 | AB | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215664-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215664-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215664-003 | AB | 1 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | 52cf3ba9-0a7c-4809-830e-af93d1532726 | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE CARBAMAZEPINE |
| CARBAMAZEPINE | CARBAMAZEPINE | Torrent Pharmaceuticals Limited | 97e6e175-75e8-437b-b457-ddb1ae4e857d | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | REMEDYREPACK INC. | 9f3d91cd-a959-4e07-a51b-8a4e9ba9ece2 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| CARBAMAZEPINE | CARBAMAZEPINE | American Health Packaging | 7108d630-89bc-4815-b6fb-a1f4676c496e | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | REMEDYREPACK INC. | 9471b7fb-29d3-4009-9d0f-f20c27351db5 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | REMEDYREPACK INC. | 40bf2923-24b1-4af1-8d20-03cf06b455a5 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| Tegretol | CARBAMAZEPINE | Novartis Pharmaceuticals Corporation | 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE |
| CARBAMAZEPINE | CARBAMAZEPINE | Major Pharmaceuticals | 2a8c7366-ce89-47ce-8123-96f26812fca0 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | REMEDYREPACK INC. | d0121be3-b904-41d3-a81a-292aa4176491 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| CARBAMAZEPINE | CARBAMAZEPINE | Bionpharma Inc., | 138d9ed1-2f8e-d19d-e063-6394a90a695d | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | REMEDYREPACK INC. | 8cc7288c-4a7e-417c-9ceb-0e0f8aeeacb3 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| CARBAMAZEPINE | CARBAMAZEPINE | Coupler LLC | 5461e739-0f18-b012-e063-6394a90a6b14 | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | Coupler LLC | 544e3b55-c8a3-a480-e063-6394a90abbb5 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| CARBAMAZEPINE | CARBAMAZEPINE | REMEDYREPACK INC. | 5f9535b1-ff6a-41b3-bbb2-efcf8fbacf4c | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | CARBAMAZEPINE CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | REMEDYREPACK INC. | cd8b51f4-8427-4b18-9d2c-10771d2a6580 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | Umedica Laboratories USA Inc. | f3465f71-8931-43b6-baea-eac7046a4400 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | A-S Medication Solutions | 1dc2a4d3-2ebc-4c9b-a347-92acd9f231f2 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | Ajanta Pharma USA Inc. | 2e3c4854-89a1-4e3f-88d4-e164829585fb | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | Bryant Ranch Prepack | d3cd36c4-b25e-4716-be1d-0b2c83ea6a03 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |
| Carbamazepine | CARBAMAZEPINE | Umedica Laboratories USA Inc. | 48080efd-1781-4585-83f8-c43957ac63b3 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | Carbamazepine CARBAMAZEPINE |