Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062921
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE;INJECTION Prescription AP No Yes
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE;INJECTION Prescription AP No Yes
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE;INJECTION Prescription AP No 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
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
01/19/2018 SUPPL-26 Labeling-Container/Carton Labels

Label is not available on this site.

07/25/2012 SUPPL-22 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062921s022lbl.pdf
11/18/2010 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

02/15/2007 SUPPL-18 Labeling

Label is not available on this site.

07/28/2003 SUPPL-15 Labeling

Label is not available on this site.

09/19/2000 SUPPL-14 Labeling

Label is not available on this site.

08/24/1999 SUPPL-13 Labeling

Label is not available on this site.

12/01/1998 SUPPL-12 Labeling

Label is not available on this site.

04/30/1997 SUPPL-11 Labeling

Label is not available on this site.

07/29/1996 SUPPL-10 Labeling

Label is not available on this site.

02/24/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/24/1995 SUPPL-8 Labeling

Label is not available on this site.

11/16/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/28/1993 SUPPL-6 Labeling

Label is not available on this site.

10/31/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/27/1993 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-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062921s022lbl.pdf

DOXORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION; 10MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE;INJECTION Prescription No AP 063097 PHARMACHEMIE BV
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE;INJECTION Prescription No AP 062921 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 20MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE;INJECTION Prescription No AP 208888 AMNEAL
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE;INJECTION Prescription No AP 063097 PHARMACHEMIE BV
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE;INJECTION Prescription No AP 062921 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 50MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE;INJECTION Prescription No AP 208888 AMNEAL
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE;INJECTION Prescription No AP 200170 MYLAN LABS LTD
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE;INJECTION Prescription No AP 063097 PHARMACHEMIE BV
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE;INJECTION Prescription No AP 062921 WEST-WARD PHARMS INT

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English