Product NDC: | 47584-002 |
Proprietary Name: | Sodium Fluoride |
Non Proprietary Name: | SODIUM FLUORIDE F-18 |
Active Ingredient(s): | 200 mCi/mL & nbsp; SODIUM FLUORIDE F-18 |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 47584-002 |
Labeler Name: | Houston Cyclotron Partners LP dba Cyclotope |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA203544 |
Marketing Category: | ANDA |
Start Marketing Date: | 20111208 |
Package NDC: | 47584-002-01 |
Package Description: | 30 mL in 1 VIAL, GLASS (47584-002-01) |
NDC Code | 47584-002-01 |
Proprietary Name | Sodium Fluoride |
Package Description | 30 mL in 1 VIAL, GLASS (47584-002-01) |
Product NDC | 47584-002 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | SODIUM FLUORIDE F-18 |
Dosage Form Name | INJECTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20111208 |
Marketing Category Name | ANDA |
Labeler Name | Houston Cyclotron Partners LP dba Cyclotope |
Substance Name | SODIUM FLUORIDE F-18 |
Strength Number | 200 |
Strength Unit | mCi/mL |
Pharmaceutical Classes | Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] |