Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050724
Company: LEADIANT BIOSCI INC
Company: LEADIANT BIOSCI INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ABELCET | AMPHOTERICIN B | 5MG/ML | INJECTABLE, LIPID COMPLEX;INJECTION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/20/1995 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
---|---|---|---|---|---|
12/23/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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08/06/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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09/29/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/20/1999 | SUPPL-9 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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08/10/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/11/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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08/13/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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09/20/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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10/18/1996 | SUPPL-2 | Efficacy-New Indication |
Label is not available on this site. |