Aprepitant

Prevents postoperative nausea and vomiting (PONV). ANDA 211835, held by Torrent. Aprepitant.

As of Nov 13, 2026, ANDA 211835 (Aprepitant), held by Torrent, was first approved by FDA on Oct 21, 2020, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 21, 2020
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules are indicated

in combination with other antiemetic agents, in patients 12 years of age and older for prevention of: o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)
for prevention of postoperative nausea and vomiting (PONV) in adults Limitations of Use:
Aprepitant has not been studied for treatment of established nausea and vomiting.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 21, 2020	Original application	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Aprepitant40MG · capsule;oral	Aprepitant	Rx
Aprepitant80MG · capsule;oral	Aprepitant	Rx
Aprepitant125MG · capsule;oral	Aprepitant	Rx

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 12, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Oct 21, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 211835
Drugs@FDA: Overview at FDA
Company: Torrent Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters