Product NDC: | 0085-1417 |
Proprietary Name: | TEMODAR |
Non Proprietary Name: | Temozolomide |
Active Ingredient(s): | 250 mg/1 & nbsp; Temozolomide |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0085-1417 |
Labeler Name: | Merck Sharp & Dohme Corp. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021029 |
Marketing Category: | NDA |
Start Marketing Date: | 19990811 |
Package NDC: | 0085-1417-01 |
Package Description: | 1 BOTTLE, GLASS in 1 CARTON (0085-1417-01) > 5 CAPSULE in 1 BOTTLE, GLASS |
NDC Code | 0085-1417-01 |
Proprietary Name | TEMODAR |
Package Description | 1 BOTTLE, GLASS in 1 CARTON (0085-1417-01) > 5 CAPSULE in 1 BOTTLE, GLASS |
Product NDC | 0085-1417 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Temozolomide |
Dosage Form Name | CAPSULE |
Route Name | ORAL |
Start Marketing Date | 19990811 |
Marketing Category Name | NDA |
Labeler Name | Merck Sharp & Dohme Corp. |
Substance Name | TEMOZOLOMIDE |
Strength Number | 250 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |