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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091620
Company: SANDOZ

Products on ANDA 091620

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 ANDA 091620

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
01/25/2021	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
04/09/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/09/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 091620

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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