Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213438
Company: LEADING
Company: LEADING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROXYUREA | HYDROXYUREA | 500MG | 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 |
---|---|---|---|---|---|---|---|
04/08/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
HYDROXYUREA
CAPSULE;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | Yes | AB | 016295 | CHEPLAPHARM |
HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | No | AB | 075143 | BARR |
HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | No | AB | 213438 | LEADING |
HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | No | AB | 075340 | PAR PHARM |
HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | No | AB | 218021 | QILU |