Application 219319
- Type
- ANDA
- Sponsor
- SENORES PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 100MG | No | No |
| 002 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 300MG | No | No |
| 003 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 400MG | No | No |
| 004 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219319-001 | GABAPENTIN | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2025-08-07 | |
| A219319-002 | GABAPENTIN | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2025-08-07 | |
| A219319-003 | GABAPENTIN | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2025-08-07 | |
| A219319-004 | GABAPENTIN | GABAPENTIN | 200MG | CAPSULE / ORAL | AB | 2026-05-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219319-001 | AB |
| A219319-002 | AB |
| A219319-003 | AB |
| A219319-004 | AB |
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 | A219319-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2025-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219319-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2025-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219319-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2025-08-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219319-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2025-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219319-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2025-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219319-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2025-08-07 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219319-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2025-08-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219319-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2025-08-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219319-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2025-08-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219319-004 | GABAPENTIN | 200MG | CAPSULE / ORAL | AB | 2026-05-14 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A219319-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219319-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219319-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219319-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219319-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219319-003 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219319-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219319-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219319-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219319-004 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | Pangea Pharmaceuticals, LLC | 5eff7ad8-0d31-4372-82a2-ac9f549d8796 | 2026-05-22 | Warnings, Adverse reactions | 219319 ANDA219319 |
| Gabapentin | GABAPENTIN | Amici Pharma, Inc. | 1ea83c18-7107-41f4-8305-62725c1c45c8 | 2026-05-19 | Warnings, Adverse reactions | 219319 ANDA219319 |
| GABAPENTIN | GABAPENTIN | STALLION LABORATORIES PRIVATE LIMITED | b26fd0c6-6aab-4957-8a32-cc7adb9b5fc9 | 2025-10-03 | Warnings, Adverse reactions | 219319 ANDA219319 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85557 | ORIG | 2026-03-30 |