Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091620
Company: SANDOZ INC
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
05/27/2015 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
09/29/2017 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/29/2017 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

09/29/2017 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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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