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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217559
Company: REGCON HOLDINGS

Products on ANDA 217559

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIOTEPA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217559

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/20/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217559

THIOTEPA

POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL; 15MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TEPADINA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	Yes	AP	208264	ADIENNE SA
THIOTEPA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	214222	GLAND
THIOTEPA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	216037	MEITHEAL
THIOTEPA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	213049	MSN
THIOTEPA	THIOTEPA	15MG/VIAL	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Prescription	No	AP	217559	REGCON HOLDINGS

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