NDC 66658-112
Kepivance
Palifermin
Kepivance is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Swedish Orphan Biovitrum Ab (publ). The primary component is Palifermin.
| Product ID | 66658-112_23803d17-1142-4037-bc4f-5d643de9d329 |
| NDC | 66658-112 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Kepivance |
| Generic Name | Palifermin |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2009-12-15 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125103 |
| Labeler Name | Swedish Orphan Biovitrum AB (publ) |
| Substance Name | PALIFERMIN |
| Active Ingredient Strength | 6 mg/1.2mL |
| Pharm Classes | Fibroblast Growth Factor 7 [CS],Increased Epithelial Proliferation [PE],Mucocutaneous Epithelial Cell Growth Factor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 66658-112-03
3 VIAL, SINGLE-USE in 1 CARTON (66658-112-03) > 1.2 mL in 1 VIAL, SINGLE-USE (66658-112-01)
| Marketing Start Date | 2009-12-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 66658-112-01 [66658011201]
Kepivance INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125103 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2012-11-14 |
NDC 66658-112-03 [66658011203]
Kepivance INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125103 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-12-15 |
NDC 66658-112-24 [66658011224]
Kepivance INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125103 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-12-15 |
| Marketing End Date | 2016-04-01 |
NDC 66658-112-06 [66658011206]
Kepivance INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | BLA |
| Application Number | BLA125103 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-12-15 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PALIFERMIN | 6.25 mg/1.2mL |
OpenFDA Data
| SPL SET ID: | 426f6e64-2c20-4a61-6d65-7320426f6e64 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Fibroblast Growth Factor 7 [CS]
- Increased Epithelial Proliferation [PE]
- Mucocutaneous Epithelial Cell Growth Factor [EPC]
Trademark Results [Kepivance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KEPIVANCE 78493232 3049649 Live/Registered |
SWEDISH ORPHAN BIOVITRUM AB (PUBL) 2004-10-01 |
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