Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202857
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription AP 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
09/12/2014 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202857Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/03/2019 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

10/03/2019 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/31/2017 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/21/2016 SUPPL-8 Labeling

Label is not available on this site.

12/21/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/21/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

DAPTOMYCIN

POWDER;INTRAVENOUS; 500MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CUBICIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 021572 CUBIST PHARMS LLC
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 211961 ACCORD HLTHCARE
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 212513 BE PHARMS
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 208375 DR REDDYS
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 206077 FRESENIUS KABI USA
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 202857 HOSPIRA INC
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 212022 JIANGSU HENGRUI MED
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 205037 MYLAN LABS LTD
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 091039 TEVA PHARMS USA
DAPTOMYCIN DAPTOMYCIN 500MG/VIAL POWDER;INTRAVENOUS Prescription No AP 206005 XELLIA PHARMS APS

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