Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077139
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
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 |
---|---|---|---|---|---|---|---|
09/21/2005 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/14/2012 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077139Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077139Orig1s016ltr.pdf | |
06/06/2011 | SUPPL-6 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/14/2012 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077139Orig1s016lbl.pdf |