Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215270
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLTESTOSTERONE | METHYLTESTOSTERONE | 10MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
02/18/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
METHYLTESTOSTERONE
CAPSULE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLTESTOSTERONE | METHYLTESTOSTERONE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 204851 | IMPAX LABS INC |
METHYLTESTOSTERONE | METHYLTESTOSTERONE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 215270 | NOVITIUM PHARMA |