Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205645
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIGECYCLINE TIGECYCLINE 50MG/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
12/01/2016 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205645lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205645Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205645Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/04/2019 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205645s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205645Orig1s003ltr.pdf
08/15/2017 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205645s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205645Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/04/2019 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205645s003lbl.pdf
08/15/2017 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205645s001lbl.pdf
12/01/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205645lbl.pdf

TIGECYCLINE

POWDER;INTRAVENOUS; 50MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TIGECYCLINE TIGECYCLINE 50MG/VIAL POWDER;INTRAVENOUS Prescription No AP 211158 AMNEAL PHARMS LLC
TIGECYCLINE TIGECYCLINE 50MG/VIAL POWDER;INTRAVENOUS Prescription No AP 204439 APOTEX
TIGECYCLINE TIGECYCLINE 50MG/VIAL POWDER;INTRAVENOUS Prescription No AP 206335 AUROBINDO PHARMA LTD
TIGECYCLINE TIGECYCLINE 50MG/VIAL POWDER;INTRAVENOUS Prescription No AP 205645 FRESENIUS KABI USA
TIGECYCLINE TIGECYCLINE 50MG/VIAL POWDER;INTRAVENOUS Prescription No AP 091620 SANDOZ INC
TIGECYCLINE TIGECYCLINE 50MG/VIAL POWDER;INTRAVENOUS Prescription No AP 205722 XELLIA PHARMS APS
TYGACIL TIGECYCLINE 50MG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 021821 PF PRISM CV

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