Application 214131
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
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 |
|---|---|---|---|---|---|---|---|
| A214131-001 | LUBIPROSTONE | LUBIPROSTONE | 8MCG | CAPSULE / ORAL | AB | 2023-03-23 | |
| A214131-002 | LUBIPROSTONE | LUBIPROSTONE | 24MCG | CAPSULE / ORAL | AB | 2023-03-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214131-001 | AB |
| A214131-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A214131-001 | LUBIPROSTONE | 8MCG | CAPSULE / ORAL | AB | 2023-03-23 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A214131-002 | LUBIPROSTONE | 24MCG | CAPSULE / ORAL | AB | 2023-03-23 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A214131-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A214131-002 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Lubiprostone | LUBIPROSTONE | Asclemed USA, Inc. | 5797e57c-4e87-48d9-b16d-992f64db594f | 2025-02-06 | Warnings, Adverse reactions | 214131 ANDA214131 |
| Lubiprostone | LUBIPROSTONE | Zydus Lifesciences Limited | 81f9c9de-f89d-4ab0-a8ca-18d3691e42f9 | 2024-11-30 | 214131 ANDA214131 | |
| Lubiprostone | LUBIPROSTONE | Zydus Pharmaceuticals USA Inc. | 6c11a204-6831-4269-a3c4-1702ed83f74b | 2023-03-27 | Warnings, Adverse reactions | 214131 ANDA214131 |