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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211158
Company: AMNEAL

Products on NDA 211158

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIGECYCLINE	TIGECYCLINE	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211158

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/02/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211158s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211158Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211158Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2025	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211158s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211158Orig1s007ltr.pdf
05/12/2021	SUPPL-6		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211158s006lbl.pdf
11/10/2020	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211158s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211158Orig1s005ltr.pdf
07/31/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211158s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211158Orig1s003ltr.pdf

Labels for NDA 211158

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2025	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211158s007lbl.pdf
05/12/2021	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211158s006lbl.pdf
11/10/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211158s005lbl.pdf
07/31/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211158s003lbl.pdf
08/02/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211158s000lbl.pdf

Therapeutic Equivalents for NDA 211158

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	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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