Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062975
Company: HIKMA
Company: HIKMA
| 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 |
|---|---|---|---|---|---|---|---|
| 03/17/1989 | 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-21 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062975s021lbl.pdf | |
| 11/22/2010 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/14/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 07/28/2003 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/03/2001 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/19/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/24/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/30/1997 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/29/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/16/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1989 | SUPPL-1 | Manufacturing (CMC) |
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-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062975s021lbl.pdf |
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 |