Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050731
Company: WEST-WARD PHARMS INT
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 No AP 208759 HISUN PHARM HANGZHOU
DAUNORUBICIN HYDROCHLORIDE DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 065035 TEVA PHARMS USA
DAUNORUBICIN HYDROCHLORIDE DAUNORUBICIN HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 050731 WEST-WARD PHARMS INT

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