Sunitinib malate
- Product NDC
- 63304-092
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sunitinib malate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries Inc.
- Application
- ANDA213914
- Marketing category
- ANDA
- Substance
- SUNITINIB MALATE
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 63304-092-27 | 28 CAPSULE in 1 BOTTLE (63304-092-27) | 20191225 | | No | Historical |
| 63304-092-86 | 4 BLISTER PACK in 1 BOX (63304-092-86) / 7 CAPSULE in 1 BLISTER PACK (63304-092-11) | 20191225 | | No | Historical |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|
| 06e0ad28-6637-4f54-879c-2c194aece5fd | These highlights do not include all the information needed to use SUNITINIB MALATE CAPSULES safely and effectively. See full prescribing information for SUNITINIB MALATE CAPSULES. SUNITINIB malate capsules, for oral use Initial U.S. Approval: 2006 | Sun Pharmaceutical Industries Inc. | Sun Pharmaceutical Industries Limited | 2024-12-17 | HUMAN PRESCRIPTION DRUG LABEL | 8 |