Application 204982
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 3.75MG BASE;23MG | No | No |
| 002 | PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 7.5MG BASE;46MG | No | No |
| 003 | PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 11.25MG BASE;69MG | No | No |
| 004 | PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 15MG BASE;92MG | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82594 | SUPPL | 2025-06-17 |
| 78907 | ORIG | 2024-06-27 |