Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021821
Company: PF PRISM CV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TYGACIL TIGECYCLINE 50MG/VIAL POWDER;INTRAVENOUS Prescription AP Yes 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
06/15/2005 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021821lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021821ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-821_Tygacil.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/16/2018 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021821s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021821Orig1s045ltr.pdf
01/19/2016 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021821Orig1s043ltr.pdf
06/29/2016 SUPPL-42 Labeling-Package Insert 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/2016/021821s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021821Orig1s042ltr.pdf
05/31/2016 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021821Orig1s039ltr.pdf
05/23/2013 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021821Orig1s037ltr.pdf
01/09/2014 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/26/2013 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s026s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021821Orig1s026,s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021821Orig1s031.pdf
07/16/2010 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021821s021,021821s025,021821s027ltr.pdf
09/26/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s026s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021821Orig1s026,s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021821Orig1s026.pdf
07/16/2010 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021821s021,021821s025,021821s027ltr.pdf
06/26/2009 SUPPL-22 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s022ltr.pdf
07/16/2010 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021821s021,021821s025,021821s027ltr.pdf
01/29/2009 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s011s014s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s011,021821s014,021821s019ltr.pdf
03/20/2009 SUPPL-18 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s013,021821s017,021821s018ltr.pdf
03/20/2009 SUPPL-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s013,021821s017,021821s018ltr.pdf
02/10/2009 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s016ltr.pdf
01/29/2009 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s011s014s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s011,021821s014,021821s019ltr.pdf
03/20/2009 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s013,021821s017,021821s018ltr.pdf
01/29/2009 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s011,021821s014,021821s019ltr.pdf
05/18/2007 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021821s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021821s010ltr.pdf
04/03/2007 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021821s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021821s007ltr.pdf
01/24/2007 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021821s006ltr.pdf
07/12/2006 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021821s003, 021821s004_ltr.pdf
07/12/2006 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021821s003, 021821s004_ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/16/2018 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021821s045lbl.pdf
06/29/2016 SUPPL-42 Labeling-Package Insert 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/2016/021821s042lbl.pdf
05/31/2016 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s039lbl.pdf
01/19/2016 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s043lbl.pdf
09/26/2013 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s026s031lbl.pdf
09/26/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s026s031lbl.pdf
05/23/2013 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s037lbl.pdf
07/16/2010 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s027lbl.pdf
07/16/2010 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s025lbl.pdf
07/16/2010 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s021lbl.pdf
03/20/2009 SUPPL-18 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf
03/20/2009 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf
03/20/2009 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf
02/10/2009 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s016lbl.pdf
01/29/2009 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s011s014s019lbl.pdf
01/29/2009 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s011s014s019lbl.pdf
05/18/2007 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021821s010lbl.pdf
04/03/2007 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021821s007lbl.pdf
06/15/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021821lbl.pdf

TYGACIL

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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