Application 216193
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
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 |
|---|---|---|---|---|---|---|---|
| A216193-001 | CARBAMAZEPINE | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | ||
| A216193-002 | CARBAMAZEPINE | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | ||
| A216193-003 | CARBAMAZEPINE | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216193-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216193-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216193-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216193-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216193-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216193-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216193-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216193-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A216193-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A216193-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A216193-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216193-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216193-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216193-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A216193-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A216193-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A216193-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A216193-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A216193-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A216193-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216193-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216193-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216193-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216193-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216193-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216193-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216193-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-03-24 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216193-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-03-24 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216193-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-03-24 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A216193-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-03-24 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A216193-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-03-24 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A216193-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-03-24 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A216193-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-03-24 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | A216193-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-03-24 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | A216193-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-03-24 | 053a50430f4f… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216193-001 | CARBAMAZEPINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216193-002 | CARBAMAZEPINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216193-003 | CARBAMAZEPINE | 400MG | TABLET, EXTENDED RELEASE / ORAL | 2023-03-24 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216193-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216193-002 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216193-003 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A216193-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A216193-002 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A216193-003 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A216193-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A216193-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A216193-003 | AB | 1 | 053a50430f4f… |
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 | Ajanta Pharma USA Inc. | 2e3c4854-89a1-4e3f-88d4-e164829585fb | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 216193 ANDA216193 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.