Cytarabine is a Intrathecal; Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Cytarabine.
| Product ID | 68083-343_47628a16-dba0-4e55-ac61-70fc4d94730a |
| NDC | 68083-343 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Cytarabine |
| Generic Name | Cytarabine |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS |
| Marketing Start Date | 2019-12-23 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA211937 |
| Labeler Name | Gland Pharma Limited |
| Substance Name | CYTARABINE |
| Active Ingredient Strength | 20 mg/mL |
| Pharm Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2019-12-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA211937 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-12-23 |
| Marketing Category | ANDA |
| Application Number | ANDA211937 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-12-23 |
| Ingredient | Strength |
|---|---|
| CYTARABINE | 20 mg/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 61703-303 | CYTARABINE | CYTARABINE |
| 61703-304 | Cytarabine | CYTARABINE |
| 61703-305 | Cytarabine | CYTARABINE |
| 61703-319 | Cytarabine | CYTARABINE |
| 63323-120 | Cytarabine | CYTARABINE |
| 67457-452 | Cytarabine | Cytarabine |
| 67457-454 | Cytarabine | Cytarabine |
| 67457-455 | cytarabine | cytarabine |
| 68083-337 | Cytarabine | Cytarabine |
| 68083-343 | Cytarabine | Cytarabine |
| 71288-108 | Cytarabine | Cytarabine |
| 71288-109 | Cytarabine | Cytarabine |
| 71288-168 | Cytarabine | Cytarabine |
| 71288-169 | Cytarabine | Cytarabine |