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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211835
Company: TORRENT

Products on ANDA 211835

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APREPITANT	APREPITANT	40MG	CAPSULE;ORAL	Prescription	AB	No	No
APREPITANT	APREPITANT	80MG	CAPSULE;ORAL	Prescription	AB	No	No
APREPITANT	APREPITANT	125MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211835

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/12/2022	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211835

APREPITANT

CAPSULE;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APREPITANT	APREPITANT	40MG	CAPSULE;ORAL	Prescription	No	AB	207777	GLENMARK SPECLT
APREPITANT	APREPITANT	40MG	CAPSULE;ORAL	Prescription	No	AB	090999	SANDOZ
APREPITANT	APREPITANT	40MG	CAPSULE;ORAL	Prescription	No	AB	211835	TORRENT

CAPSULE;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APREPITANT	APREPITANT	80MG	CAPSULE;ORAL	Prescription	No	AB	207777	GLENMARK SPECLT
APREPITANT	APREPITANT	80MG	CAPSULE;ORAL	Prescription	No	AB	090999	SANDOZ
APREPITANT	APREPITANT	80MG	CAPSULE;ORAL	Prescription	No	AB	211835	TORRENT
EMEND	APREPITANT	80MG	CAPSULE;ORAL	Prescription	Yes	AB	021549	MSD

CAPSULE;ORAL; 125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APREPITANT	APREPITANT	125MG	CAPSULE;ORAL	Prescription	No	AB	207777	GLENMARK SPECLT
APREPITANT	APREPITANT	125MG	CAPSULE;ORAL	Prescription	No	AB	090999	SANDOZ
APREPITANT	APREPITANT	125MG	CAPSULE;ORAL	Prescription	No	AB	211835	TORRENT
EMEND	APREPITANT	125MG	CAPSULE;ORAL	Prescription	Yes	AB	021549	MSD

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