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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205645
Company: FRESENIUS KABI USA

Products on NDA 205645

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIGECYCLINE	TIGECYCLINE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205645

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
11/16/2020	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205645s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205645Orig1s004ltr.pdf
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

Labels for NDA 205645

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205645s004lbl.pdf
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

Therapeutic Equivalents for NDA 205645

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
TIGECYCLINE	TIGECYCLINE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	204439	APOTEX
TIGECYCLINE	TIGECYCLINE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	206335	EUGIA PHARMA
TIGECYCLINE	TIGECYCLINE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	205645	FRESENIUS KABI USA
TIGECYCLINE	TIGECYCLINE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	214020	MEITHEAL
TIGECYCLINE	TIGECYCLINE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	091620	SANDOZ
TYGACIL	TIGECYCLINE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	021821	PF PRISM CV

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