Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205646
Company: HETERO LABS LTD V

Products on ANDA 205646

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	AB	No	No
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205646

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/06/2022	ORIG-2	Approval		STANDARD		Label is not available on this site.
07/16/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 205646

TOLVAPTAN

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SAMSCA	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	Yes	AB	022275	OTSUKA
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB	211891	ALKEM LABS LTD
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB	207605	APOTEX
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB	206119	ENDO OPERATIONS
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB	205646	HETERO LABS LTD V
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB	216949	MSN

TABLET;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SAMSCA	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	Yes	AB	022275	OTSUKA
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB	211891	ALKEM LABS LTD
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB	207605	APOTEX
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB	206119	ENDO OPERATIONS
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB	205646	HETERO LABS LTD V
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB	216949	MSN