Details for New Drug Application (NDA): 211835

NDA 211835 describes APREPITANT, which is a drug marketed by Glenmark Speclt, Sandoz, and Torrent, and is included in three NDAs. It is available from three suppliers. Additional details are available on the APREPITANT profile page.

The generic ingredient in APREPITANT is aprepitant. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aprepitant profile page.

Summary for 211835

Tradename:	APREPITANT
Applicant:	Torrent
Ingredient:	aprepitant
Patents:	0

Pharmacology for NDA: 211835

Mechanism of Action

Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists

Suppliers and Packaging for NDA: 211835

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
APREPITANT	aprepitant	CAPSULE;ORAL	211835	ANDA	Torrent Pharmaceuticals Limited	13668-591	13668-591-81	1 BLISTER PACK in 1 CARTON (13668-591-81) / 1 CAPSULE in 1 BLISTER PACK (13668-591-80)
APREPITANT	aprepitant	CAPSULE;ORAL	211835	ANDA	Torrent Pharmaceuticals Limited	13668-591	13668-591-82	5 BLISTER PACK in 1 CARTON (13668-591-82) / 1 CAPSULE in 1 BLISTER PACK (13668-591-80)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	Oct 21, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	80MG
Approval Date:	Oct 21, 2020	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	125MG
Approval Date:	Oct 21, 2020	TE:	AB	RLD:	No

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