Last Updated: September 24, 2026

Details for New Drug Application (NDA): 211835


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

The generic ingredient in APREPITANT is aprepitant. There is one drug master file entry for this compound. Seven 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 ActionCytochrome 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:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:Oct 21, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength80MG
Approval Date:Oct 21, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength125MG
Approval Date:Oct 21, 2020TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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