Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216201
Company: ETON
Company: ETON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NITISINONE | NITISINONE | 2MG | CAPSULE;ORAL | Prescription | AB | No | No |
NITISINONE | NITISINONE | 5MG | CAPSULE;ORAL | Prescription | AB | No | No |
NITISINONE | NITISINONE | 10MG | CAPSULE;ORAL | Prescription | AB | No | No |
NITISINONE | NITISINONE | 20MG | 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 |
---|---|---|---|---|---|---|---|
05/25/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
NITISINONE
CAPSULE;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITISINONE | NITISINONE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 216201 | ETON |
NITISINONE | NITISINONE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 212390 | MEDUNIK |
NITISINONE | NITISINONE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 211041 | NOVITIUM PHARMA |
ORFADIN | NITISINONE | 2MG | CAPSULE;ORAL | Prescription | Yes | AB | 021232 | SWEDISH ORPHAN |
CAPSULE;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITISINONE | NITISINONE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 216201 | ETON |
NITISINONE | NITISINONE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 212390 | MEDUNIK |
NITISINONE | NITISINONE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 211041 | NOVITIUM PHARMA |
ORFADIN | NITISINONE | 5MG | CAPSULE;ORAL | Prescription | Yes | AB | 021232 | SWEDISH ORPHAN |
CAPSULE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITISINONE | NITISINONE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 216201 | ETON |
NITISINONE | NITISINONE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 212390 | MEDUNIK |
NITISINONE | NITISINONE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 211041 | NOVITIUM PHARMA |
ORFADIN | NITISINONE | 10MG | CAPSULE;ORAL | Prescription | Yes | AB | 021232 | SWEDISH ORPHAN |
CAPSULE;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NITISINONE | NITISINONE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 216201 | ETON |
NITISINONE | NITISINONE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 212390 | MEDUNIK |
ORFADIN | NITISINONE | 20MG | CAPSULE;ORAL | Prescription | Yes | AB | 021232 | SWEDISH ORPHAN |