Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064140
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 2MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 200MG/100ML | 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 |
|---|---|---|---|---|---|---|---|
| 07/28/1995 | 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 |
|---|---|---|---|---|---|
| 12/12/2014 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2013 | SUPPL-27 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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| 05/08/2001 | SUPPL-7 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 10/06/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/08/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/08/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 06/08/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/29/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 07/24/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |