U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208657
Company: DR REDDYS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription AB No No
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription AB 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
05/15/2017 ORIG-1 Approval STANDARD Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208657Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/2020 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
11/03/2017 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

INJECTABLE, LIPOSOMAL;INJECTION; 20MG/10ML (2MG/ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXIL (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription Yes AB 050718 BAXTER HLTHCARE CORP
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 207228 AYANA PHARMA LTD
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 212219 BAXTER HLTHCARE CORP
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 208657 DR REDDYS
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 203263 SUN PHARM
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 212299 ZYDUS LIFESCIENCES

INJECTABLE, LIPOSOMAL;INJECTION; 50MG/25ML (2MG/ML)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXIL (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription Yes AB 050718 BAXTER HLTHCARE CORP
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 207228 AYANA PHARMA LTD
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 212219 BAXTER HLTHCARE CORP
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 208657 DR REDDYS
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 203263 SUN PHARM
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 212299 ZYDUS LIFESCIENCES
Back to Top