NDC Code | 0480-3296-56 |
Package Description | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3296-56) |
Product NDC | 0480-3296 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Phentermine And Topiramate |
Non-Proprietary Name | Phentermine And Topiramate |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20250507 |
Marketing Category Name | ANDA |
Application Number | ANDA204982 |
Manufacturer | Teva Pharmaceuticals, Inc. |
Substance Name | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE |
Strength | 7.5; 46 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC] |
DEA Schedule | CIV |