Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063097
Company: PHARMACHEMIE BV
Company: PHARMACHEMIE BV
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 10MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 20MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 05/21/1990 | 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 |
|---|---|---|---|---|---|
| 08/14/2003 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 09/18/2002 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 09/19/2002 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/25/2000 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 08/25/2000 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 02/15/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/30/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 07/13/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 06/07/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 01/29/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 01/29/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/29/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/29/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/29/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/26/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |