Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078631
Company: PLIVA LACHEMA
Company: PLIVA LACHEMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBOPLATIN | CARBOPLATIN | 50MG/5ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
| CARBOPLATIN | CARBOPLATIN | 150MG/15ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
| CARBOPLATIN | CARBOPLATIN | 450MG/45ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
| CARBOPLATIN | CARBOPLATIN | 600MG/60ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 12/02/2008 | ORIG-1 | Approval |
Label is not available on this site. |