Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204982
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/25/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204982Orig1s000ltr.pdf |
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE
CAPSULE, EXTENDED RELEASE;ORAL; EQ 3.75MG BASE;23MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204982 | ACTAVIS LABS FL INC |
| QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022580 | VIVUS LLC |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 7.5MG BASE;46MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204982 | ACTAVIS LABS FL INC |
| QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022580 | VIVUS LLC |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 11.25MG BASE;69MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204982 | ACTAVIS LABS FL INC |
| QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022580 | VIVUS LLC |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 15MG BASE;92MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204982 | ACTAVIS LABS FL INC |
| QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022580 | VIVUS LLC |