Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063277
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 10/26/1995 | 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 |
|---|---|---|---|---|---|
| 11/05/2014 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/14/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/05/2002 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/20/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/20/2000 | SUPPL-9 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 07/20/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/29/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/10/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/10/1997 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 01/10/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DOXORUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION; 2MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203622 | ACTAVIS INC |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 063277 | FRESENIUS KABI USA |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209825 | GLAND PHARMA LTD |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062975 | HIKMA |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 050629 | PFIZER |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091495 | SAGENT PHARMS |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091418 | SUN PHARM INDS |