Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019880
Company: CORDEN PHARMA
Company: CORDEN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PARAPLATIN | CARBOPLATIN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| PARAPLATIN | CARBOPLATIN | 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| PARAPLATIN | CARBOPLATIN | 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/03/1989 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/05/2010 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019880s020ltr.pdf |
| 03/21/2002 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/02/2000 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/2001 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/14/2000 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/07/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/30/2001 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/14/2002 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19880s11ltr.pdf |
| 11/15/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/06/1998 | SUPPL-9 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19880S009_Paraplatin.pdf |
| 03/17/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/23/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/17/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1990 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/1991 | SUPPL-1 | Efficacy-New Indication |
Label is not available on this site. |