Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078188
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
02/27/2008 | 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 |
---|---|---|---|---|---|
03/16/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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05/26/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
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06/21/2010 | SUPPL-2 | Labeling |
Label is not available on this site. |