Dronabinol

ANDA 201463, held by Lannett Co Inc. Dronabinol.

As of Nov 13, 2026, ANDA 201463 (Dronabinol), held by Lannett Co Inc, was first approved by FDA on May 18, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: May 18, 2018
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
May 18, 2018	Original application	Approved	None posted

Products

3 strengths and forms


Dronabinol2.5MG · capsule;oral	Dronabinol	Discontinued
Dronabinol5MG · capsule;oral	Dronabinol	Discontinued
Dronabinol10MG · capsule;oral	Dronabinol	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 14, 2021	Supplement 6Manufacturing · Standard review	Approved	None posted
May 18, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 201463
Drugs@FDA: Overview at FDA
Company: Lannett Company

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