Product NDC: | 0008-1030 |
Proprietary Name: | Rapamune |
Non Proprietary Name: | SIROLIMUS |
Active Ingredient(s): | 1 mg/mL & nbsp; SIROLIMUS |
Administration Route(s): | ORAL |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0008-1030 |
Labeler Name: | Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021083 |
Marketing Category: | NDA |
Start Marketing Date: | 19990901 |
Package NDC: | 0008-1030-06 |
Package Description: | 1 CARTON in 1 KIT (0008-1030-06) > 1 BOTTLE, GLASS in 1 CARTON (0008-1030-04) > 60 mL in 1 BOTTLE, GLASS |
NDC Code | 0008-1030-06 |
Proprietary Name | Rapamune |
Package Description | 1 CARTON in 1 KIT (0008-1030-06) > 1 BOTTLE, GLASS in 1 CARTON (0008-1030-04) > 60 mL in 1 BOTTLE, GLASS |
Product NDC | 0008-1030 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | SIROLIMUS |
Dosage Form Name | SOLUTION |
Route Name | ORAL |
Start Marketing Date | 19990901 |
Marketing Category Name | NDA |
Labeler Name | Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc. |
Substance Name | SIROLIMUS |
Strength Number | 1 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA] |