Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040618
Company: NOVAST LABS
Company: NOVAST LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROBENECID AND COLCHICINE | COLCHICINE; PROBENECID | 0.5MG;500MG | TABLET;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 |
---|---|---|---|---|---|---|---|
05/13/2008 | ORIG-1 | Approval |
Label is not available on this site. |
PROBENECID AND COLCHICINE
TABLET;ORAL; 0.5MG;500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
COL-PROBENECID | COLCHICINE; PROBENECID | 0.5MG;500MG | TABLET;ORAL | Prescription | Yes | AB | 084279 | WATSON LABS |
PROBENECID AND COLCHICINE | COLCHICINE; PROBENECID | 0.5MG;500MG | TABLET;ORAL | Prescription | No | AB | 040618 | NOVAST LABS |
PROBENECID AND COLCHICINE | COLCHICINE; PROBENECID | 0.5MG;500MG | TABLET;ORAL | Prescription | No | AB | 217030 | RISING |