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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207777
Company: GLENMARK PHARMS SA

Products on ANDA 207777

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 207777

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/12/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207777

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 PHARMS SA
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 PHARMS SA
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	MERCK

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 PHARMS SA
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	MERCK

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