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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211891
Company: ALKEM LABS LTD

Products on ANDA 211891

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	AB1	No	No
TOLVAPTAN	TOLVAPTAN	60MG	TABLET;ORAL	Prescription	None	No	No
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211891

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/2020/211891Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2022	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211891

TOLVAPTAN

TABLET;ORAL; 30MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SAMSCA	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	Yes	AB1	022275	OTSUKA
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB1	211891	ALKEM LABS LTD
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB1	207605	APOTEX
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB1	205646	HETERO LABS LTD V
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB1	216949	MSN
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB1	206119	PH HEALTH

TABLET;ORAL; 15MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SAMSCA	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	Yes	AB1	022275	OTSUKA
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB1	211891	ALKEM LABS LTD
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB1	207605	APOTEX
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB1	205646	HETERO LABS LTD V
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB1	216949	MSN
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB1	206119	PH HEALTH

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