NDC 70688-0502
Kynamro
Mipomersen Sodium
Kynamro is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Kastle Therapeutics, Llc. The primary component is Mipomersen Sodium.
| Product ID | 70688-0502_900bb03a-deb5-4522-8dc1-755994b073b6 |
| NDC | 70688-0502 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Kynamro |
| Generic Name | Mipomersen Sodium |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 2016-05-02 |
| Marketing Category | NDA / NDA |
| Application Number | NDA203568 |
| Labeler Name | Kastle Therapeutics, LLC |
| Substance Name | MIPOMERSEN SODIUM |
| Active Ingredient Strength | 200 mg/mL |
| Pharm Classes | Apolipoprotein B-100 Synthesis Inhibitor [EPC],Decreased Protein Synthesis [PE],Antisense Oligonucleotide [EPC],Oligonucleotides, Antisense [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
Packaging
NDC 70688-0502-1
1 SYRINGE in 1 CARTON (70688-0502-1) > 1 mL in 1 SYRINGE
| Marketing Start Date | 2016-05-02 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 70688-0502-2 [70688050202]
Kynamro INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA203568 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-05-02 |
| Inactivation Date | 2020-01-31 |
NDC 70688-0502-1 [70688050201]
Kynamro INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA203568 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-05-02 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| MIPOMERSEN SODIUM | 200 mg/mL |
OpenFDA Data
| SPL SET ID: | 774c7847-490b-41d5-9e0e-2baedbc94f62 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Apolipoprotein B-100 Synthesis Inhibitor [EPC]
- Decreased Protein Synthesis [PE]
- Antisense Oligonucleotide [EPC]
- Oligonucleotides
- Antisense [CS]
Trademark Results [Kynamro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KYNAMRO 85066383 4392642 Live/Registered |
KASTLE THERAPEUTICS, LLC 2010-06-18 |
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