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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207605
Company: APOTEX

Products on ANDA 207605

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 207605

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.
05/19/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207605Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/08/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207605

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

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