Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203263
Company: SUN PHARM
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 Yes
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription AB 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
02/04/2013 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203263lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203263Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203263Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/03/2017 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

08/25/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/21/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

12/12/2014 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/04/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203263lbl.pdf

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 208657 DR REDDYS LABS LTD
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 20MG/10ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 203263 SUN PHARM

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 208657 DR REDDYS LABS LTD
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 203263 SUN PHARM

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