Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215041
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RIFABUTIN | RIFABUTIN | 150MG | 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 |
---|---|---|---|---|---|---|---|
12/17/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
RIFABUTIN
CAPSULE;ORAL; 150MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MYCOBUTIN | RIFABUTIN | 150MG | CAPSULE;ORAL | Prescription | Yes | AB | 050689 | PFIZER |
RIFABUTIN | RIFABUTIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 090033 | LUPIN LTD |
RIFABUTIN | RIFABUTIN | 150MG | CAPSULE;ORAL | Prescription | No | AB | 215041 | NOVITIUM PHARMA |