Application 217914
- Type
- ANDA
- Sponsor
- PAI HOLDINGS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LACTULOSE | LACTULOSE | FOR SOLUTION;ORAL | 10GM/PACKET | No | No |
| 002 | LACTULOSE | LACTULOSE | FOR SOLUTION;ORAL | 20GM/PACKET | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217914-001 | LACTULOSE | LACTULOSE | 10GM/PACKET | FOR SOLUTION / ORAL | AA | 2025-03-14 | |
| A217914-002 | LACTULOSE | LACTULOSE | 20GM/PACKET | FOR SOLUTION / ORAL | AA | 2025-03-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217914-001 | AA |
| A217914-002 | AA |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A217914-001 | LACTULOSE | 10GM/PACKET | FOR SOLUTION / ORAL | AA | 2025-03-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217914-002 | LACTULOSE | 20GM/PACKET | FOR SOLUTION / ORAL | AA | 2025-03-14 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A217914-001 | LACTULOSE | 10GM/PACKET | FOR SOLUTION / ORAL | AA | 2025-03-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217914-002 | LACTULOSE | 20GM/PACKET | FOR SOLUTION / ORAL | AA | 2025-03-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217914-001 | LACTULOSE | 10GM/PACKET | FOR SOLUTION / ORAL | AA | 2025-03-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217914-002 | LACTULOSE | 20GM/PACKET | FOR SOLUTION / ORAL | AA | 2025-03-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217914-001 | LACTULOSE | 10GM/PACKET | FOR SOLUTION / ORAL | AA | 2025-03-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217914-002 | LACTULOSE | 20GM/PACKET | FOR SOLUTION / ORAL | AA | 2025-03-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217914-001 | LACTULOSE | 10GM/PACKET | FOR SOLUTION / ORAL | AA | 2025-03-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217914-002 | LACTULOSE | 20GM/PACKET | FOR SOLUTION / ORAL | AA | 2025-03-14 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217914-001 | LACTULOSE | 10GM/PACKET | FOR SOLUTION / ORAL | AA | 2025-03-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217914-002 | LACTULOSE | 20GM/PACKET | FOR SOLUTION / ORAL | AA | 2025-03-14 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A217914-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A217914-002 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A217914-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217914-002 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A217914-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217914-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217914-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217914-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217914-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217914-002 | AA | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217914-001 | AA | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217914-002 | AA | 1 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217914-001 | CGT | 2025-09-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217914-002 | CGT | 2025-09-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217914-001 | CGT | 2025-09-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217914-002 | CGT | 2025-09-13 | 6a471c1ec25d… |
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 |
|---|---|---|---|---|---|---|
| Lactulose | LACTULOSE | PAI Holdings, LLC dba PAI Pharma | 5ae4b6da-44df-419a-9f2b-8c4d79f635c8 | 2026-07-07 | Warnings, Adverse reactions | 217914 ANDA217914 |
| Lactulose | LACTULOSE | Trifluent Pharma, Inc. | 3eaf273a-b49d-2595-e063-6394a90a1cf6 | 2025-09-13 | Warnings, Adverse reactions | 217914 ANDA217914 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.