Application 022499
- Type
- NDA
- Sponsor
- TRIS PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLONIDINE | CLONIDINE | SUSPENSION, EXTENDED RELEASE;ORAL | EQ 0.09MG BASE/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022499-001 | CLONIDINE | CLONIDINE | EQ 0.09MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2009-12-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N022499-001 | CLONIDINE | EQ 0.09MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2009-12-03 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N022499-001 | CLONIDINE | EQ 0.09MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2009-12-03 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022499-001 | CLONIDINE | EQ 0.09MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2009-12-03 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022499-001 | CLONIDINE | EQ 0.09MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | 2009-12-03 | 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 |
|---|---|---|---|---|---|---|
| Clonidine | CLONIDINE | Mylan Pharmaceuticals Inc. | 7adfc439-e6d0-4593-87dd-0eef36d33c6d | 2026-06-23 | Warnings, Adverse reactions | Clonidine CLONIDINE |
| Nexiclon XR | CLONIDINE | Rosemont Pharmaceuticals LLC | dad35a6f-d57e-f302-e053-2995a90a9efb | 2026-04-15 | Warnings, Adverse reactions | CLONIDINE |
| Clonidine | CLONIDINE | Ingenus Pharmaceuticals, LLC | 99485427-a120-4fc7-bb61-25857d1900ec | 2025-12-05 | Warnings, Adverse reactions | Clonidine CLONIDINE |
| Clonidine | CLONIDINE | Mayne Pharma Inc. | c41eb913-5e47-46c4-9d96-9a67f8380919 | 2025-09-04 | Warnings, Adverse reactions | Clonidine CLONIDINE |
| Clonidine | CLONIDINE | Dr. Reddy's Labratories Inc. | a179570b-eef1-176a-820c-5f603d222a60 | 2024-02-05 | Warnings, Adverse reactions | Clonidine CLONIDINE |
| Clonidine | CLONIDINE | XGen Pharmaceuticals DJB, Inc. | ada02f1f-ae78-4435-879e-492ae862d504 | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | Clonidine CLONIDINE |
| Clonidine | CLONIDINE | TruPharma, LLC | 2311836b-de63-4e8c-a021-600c40110024 | 2024-01-11 | Warnings, Adverse reactions | Clonidine CLONIDINE |
| Clonidine | CLONIDINE | PALMETTO PHARMACEUTICALS INC. | e93324f1-ad83-7bbe-e053-2995a90a8c9e | 2024-01-11 | Warnings, Adverse reactions | Clonidine CLONIDINE |
| Clonidine transdermal system | CLONIDINE | Actavis Pharma, Inc. | 99a59495-2a48-4276-bbe3-cdd55a45aba4 | 2023-11-28 | Warnings, Adverse reactions | CLONIDINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.