Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203495
Company: AVANTHI INC
Company: AVANTHI INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOMAIRA | PHENTERMINE HYDROCHLORIDE | 8MG | TABLET;ORAL | Prescription | AA | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/12/2016 | ORIG-1 | Approval |
Label is not available on this site. |
LOMAIRA
TABLET;ORAL; 8MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LOMAIRA | PHENTERMINE HYDROCHLORIDE | 8MG | TABLET;ORAL | Prescription | No | AA | 203495 | AVANTHI INC |
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 8MG | TABLET;ORAL | Prescription | No | AA | 203436 | KVK TECH INC |