Application 218640
- Type
- ANDA
- Sponsor
- ASCENT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LUBIPROSTONE | LUBIPROSTONE | CAPSULE;ORAL | 8MCG | No | No |
| 002 | LUBIPROSTONE | LUBIPROSTONE | CAPSULE;ORAL | 24MCG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218640-001 | LUBIPROSTONE | LUBIPROSTONE | 8MCG | CAPSULE / ORAL | AB | 2025-01-02 | |
| A218640-002 | LUBIPROSTONE | LUBIPROSTONE | 24MCG | CAPSULE / ORAL | AB | 2025-01-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218640-001 | AB |
| A218640-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A218640-001 | LUBIPROSTONE | 8MCG | CAPSULE / ORAL | AB | 2025-01-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218640-002 | LUBIPROSTONE | 24MCG | CAPSULE / ORAL | AB | 2025-01-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218640-001 | LUBIPROSTONE | 8MCG | CAPSULE / ORAL | AB | 2025-01-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218640-002 | LUBIPROSTONE | 24MCG | CAPSULE / ORAL | AB | 2025-01-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218640-001 | LUBIPROSTONE | 8MCG | CAPSULE / ORAL | AB | 2025-01-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218640-002 | LUBIPROSTONE | 24MCG | CAPSULE / ORAL | AB | 2025-01-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218640-001 | LUBIPROSTONE | 8MCG | CAPSULE / ORAL | AB | 2025-01-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218640-002 | LUBIPROSTONE | 24MCG | CAPSULE / ORAL | AB | 2025-01-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218640-001 | LUBIPROSTONE | 8MCG | CAPSULE / ORAL | AB | 2025-01-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218640-002 | LUBIPROSTONE | 24MCG | CAPSULE / ORAL | AB | 2025-01-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218640-001 | LUBIPROSTONE | 8MCG | CAPSULE / ORAL | AB | 2025-01-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218640-002 | LUBIPROSTONE | 24MCG | CAPSULE / ORAL | AB | 2025-01-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218640-001 | LUBIPROSTONE | 8MCG | CAPSULE / ORAL | AB | 2025-01-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218640-002 | LUBIPROSTONE | 24MCG | CAPSULE / ORAL | AB | 2025-01-02 | 03ed91905a0d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218640-001 | LUBIPROSTONE | 8MCG | CAPSULE / ORAL | AB | 2025-01-02 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218640-002 | LUBIPROSTONE | 24MCG | CAPSULE / ORAL | AB | 2025-01-02 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A218640-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218640-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A218640-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218640-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218640-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218640-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A218640-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218640-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218640-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218640-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218640-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218640-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218640-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218640-002 | AB | 1 | 03ed91905a0d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218640-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218640-002 | 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 |
|---|---|---|---|---|---|---|
| Lubiprostone | LUBIPROSTONE | Northstar Rx LLC | 1626ac65-ea12-421b-9780-bfdb50a39e1a | 2025-06-25 | Warnings, Adverse reactions | 218640 ANDA218640 |
| Lubiprostone | LUBIPROSTONE | Camber Pharmaceuticals, Inc. | 6d973d7d-a43e-4495-b618-a8ad3142683d | 2025-01-22 | Warnings, Adverse reactions | 218640 ANDA218640 |