Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 63539-017 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 63539-017 | 63539-017-01 | D | Discontinued by firm | 2026-07-31 |
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021938-001 | SUTENT | SUNITINIB MALATE | EQ 12.5MG BASE | CAPSULE / ORAL | AB | RLD | 2006-01-26 |
| N021938-002 | SUTENT | SUNITINIB MALATE | EQ 25MG BASE | CAPSULE / ORAL | AB | RLD | 2006-01-26 |
| N021938-003 | SUTENT | SUNITINIB MALATE | EQ 50MG BASE | CAPSULE / ORAL | AB | RLD, RS | 2006-01-26 |
| N021938-004 | SUTENT | SUNITINIB MALATE | EQ 37.5MG BASE | CAPSULE / ORAL | AB | RLD | 2009-03-31 |
| Application-product | TE code |
|---|---|
| N021938-001 | AB |
| N021938-002 | AB |
| N021938-003 | AB |
| N021938-004 | AB |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SUTENT | SUNITINIB MALATE | Pfizer Laboratories Div Pfizer Inc | 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c | 2026-02-20 | Boxed warning, Warnings, Adverse reactions |
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNING: HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ].
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
5 WARNINGS AND PRECAUTIONS • Hepatotoxicity : Fatal liver failure has been observed. Monitor liver function tests at baseline, during each cycle, and as clinically indicated. Interrupt SUTENT for Grade 3 hepatotoxicity until resolution to Grade ≤1 or baseline and resume SUTENT at a reduced dose; discontinue if no resolution. Discontinue SUTENT in patients with Grade 4 hepatoxicity, in patients who have subsequent severe changes in liver function tests or other signs and symptoms of liver failure. ( 2.4 , 5.1 ) • Cardiovascular Events : Myocardial ischemia, myocardial infarction, heart failure, cardiomyopathy, and decreased left ventricular ejection fraction (LVEF) to below the lower limit of normal including death have occurred. Monitor for signs and symptoms of congestive heart failure and consider monitoring LVEF at baseline and periodically during treatment. Discontinue SUTENT for clinical manifestations of congestive heart failure. Interrupt and/or dose reduce for decreased LVEF. ( 5.2 ) • QT Interval Prolongation and Torsade de Pointes : Monitor patients at higher risk for developing QT interval prolongation. Consider monitoring of electrocardiograms and electrolytes. ( 5.3 ) • Hypertension : Monitor blood pressure at baseline and as clinically indicated. Initiate and/or adjust antihypertensive therapy as appropriate. Interrupt SUTENT for Grade 3 hypertension until resolution to Grade ≤1 or baseline, then resume SUTENT at a reduced dose. Discontinue SUTENT in patients who develop Grade 4 hypertension. ( 5.4 ) • Hemorrhagic Events : Tumor-related hemorrhage and viscus perforation (both with fatal events) have occurred. Perform serial complete blood counts and physical examinations. Interrupt SUTENT for Grade 3 or 4 hemorrhagic events until resolution to Grade ≤1 or baseline, then resume at a reduced dose; discontinue if no resolution. ( 5.5 ) • Tumor Lysis Syndrome (TLS) : TLS (some fatal) has been reported primarily in patients with RCC and GIST. Monitor these patients and treat as clinically indicated. ( 5.6 ) • Thrombotic microangiopathy (TMA) : TMA, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, sometimes leading to renal failure or a fatal outcome, has been reported. Discontinue SUTENT for TMA. ( 5.7 ) • Proteinuria : Renal failure or a fatal outcome has occurred. Monitor urine protein. Interrupt treatment for 24-hou...
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling. • Hepatotoxicity [see Warnings and Precautions (5.1) ] • Cardiovascular Events [see Warnings and Precautions (5.2) ] • QT Interval Prolongation and Torsade de Pointes [see Warnings and Precautions (5.3) ] • Hypertension [see Warnings and Precautions (5.4) ] • Hemorrhagic Events [see Warnings and Precautions (5.5) ] • Tumor Lysis Syndrome [see Warnings and Precautions (5.6) ] • Thrombotic Microangiopathy [see Warnings and Precautions (5.7) ] • Proteinuria [see Warnings and Precautions (5.8) ] • Dermatologic Toxicities [see Warnings and Precautions (5.9) ] • Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.10) ] • Thyroid Dysfunction [see Warnings and Precautions (5.11) ] • Hypoglycemia [see Warnings and Precautions (5.12) ] • Osteonecrosis of the Jaw [see Warnings and Precautions (5.13) ] • Impaired Wound Healing [see Warnings and Precautions (5.14) ] • The most common adverse reactions (≥25%) are fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia/altered taste, dyspepsia, and thrombocytopenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the Warnings and Precautions reflect exposure to SUTENT in 7527 patients with GIST, RCC (advanced and adjuvant), or pNET. In this pooled safety population, the most common adverse reactions (≥25%) were fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia/altered taste, dyspepsia, and thrombocytopenia. Gastrointestinal Stromal Tumor The safety of SUTENT was evaluated in Study 1, a randomized, double-blind, placebo-controlled trial in which previously treated patients with GIST received SUTENT 50 mg daily on Schedule 4/...
Table 3. Adverse Reactions Reported in ≥10% of GIST Patients Who Received SUTENT in the Double-Blind Treatment Phase and More Commonly Than in Patients Given PlaceboCommon Terminology Criteria for Adverse Events (CTCAE), version 3.0. in Study 1Adverse ReactionGISTSUTENT (N=202)Placebo (N=102)All Grades %Grade 3–4 %All Grades %Grade 3–4 %Abbreviations: GIST=gastrointestinal stromal tumor; N=number of patients.Any Adverse Reaction94569751Gastrointestinal Diarrhea404270 Mucositis/stomatitis291182 Constipation200142Metabolism/Nutrition AnorexiaIncludes decreased appetite.331295 Asthenia225113Dermatology Skin discoloration300230 Rash14190 Hand-foot syndrome144103Neurology Altered taste210120Cardiac Hypertension154110Musculoskeletal Myalgia/limb pain14191
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c71c27c5-81ab-f132-824f-21f56518b6f9 | Product name | 3 | 20250516 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63539-017-01 | SUTENT | 28 in 1 BOTTLE | CAPSULE | 28 | 6 |
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63539-017-01 | 63539001701 | 28 CAPSULE in 1 BOTTLE (63539-017-01) | 28 capsule | 2018-06-05 | 0000-00-00 | Yes | No | Current |