Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064097
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 200MG/100ML | 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 |
|---|---|---|---|---|---|---|---|
| 09/13/1994 | 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 |
|---|---|---|---|---|---|
| 07/25/2012 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064097s016lbl.pdf | |
| 11/18/2010 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/14/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/28/2003 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/19/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/24/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/30/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/23/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/25/2012 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064097s016lbl.pdf |
DOXORUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION; 200MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 200MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 203622 | ACTAVIS INC |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 200MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 064097 | HIKMA |
| DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE | 200MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 050629 | PFIZER |