Drugs@FDA: FDA-Approved Drugs
Company: GALEN (UK)
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DAUNOXOME | DAUNORUBICIN CITRATE | EQ 2MG BASE/ML | INJECTABLE, LIPOSOMAL;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 |
---|---|---|---|---|---|---|---|
04/08/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/10/2002 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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05/23/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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10/28/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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03/28/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/21/2002 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50704s8ltr.pdf |
03/23/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/26/1998 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/26/1998 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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02/24/1997 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/11/1997 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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10/11/1996 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/27/1996 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |