Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212670
Company: STRIDES PHARMA
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZILEUTON | ZILEUTON | 600MG | TABLET, 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 |
---|---|---|---|---|---|---|---|
12/16/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ZILEUTON
TABLET, EXTENDED RELEASE;ORAL; 600MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ZILEUTON | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211390 | AIZANT |
ZILEUTON | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215742 | ANNORA PHARMA |
ZILEUTON | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204929 | RISING PHARMA |
ZILEUTON | ZILEUTON | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212670 | STRIDES PHARMA |