Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 206430
Company: CUSTOPHARM INC
Company: CUSTOPHARM INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALRUBICIN | VALRUBICIN | 40MG/ML | SOLUTION;INTRAVESICAL | Prescription | AO | 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 |
|---|---|---|---|---|---|---|---|
| 04/19/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
VALRUBICIN
SOLUTION;INTRAVESICAL; 40MG/ML
TE Code = AO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VALRUBICIN | VALRUBICIN | 40MG/ML | SOLUTION;INTRAVESICAL | Prescription | No | AO | 206430 | CUSTOPHARM INC |
| VALSTAR PRESERVATIVE FREE | VALRUBICIN | 40MG/ML | SOLUTION;INTRAVESICAL | Prescription | Yes | AO | 020892 | ENDO PHARM |
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