Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050731
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DAUNORUBICIN HYDROCHLORIDE | DAUNORUBICIN HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/30/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50731.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/27/2018 | SUPPL-8 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050731Orig1s008Rplacementltr.pdf | |
06/12/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/02/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/29/1999 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
DAUNORUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 5MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DAUNORUBICIN HYDROCHLORIDE | DAUNORUBICIN HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 050731 | HIKMA |
DAUNORUBICIN HYDROCHLORIDE | DAUNORUBICIN HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208759 | HISUN PHARM HANGZHOU |
DAUNORUBICIN HYDROCHLORIDE | DAUNORUBICIN HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065035 | MEITHEAL |