Fentanyl Citrate

ANDA 206329, held by Dr Reddys Labs SA. Fentanyl Citrate.

As of Nov 14, 2026, ANDA 206329 (Fentanyl Citrate), held by Dr Reddys Labs SA, was first approved by FDA on Aug 22, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 22, 2022
Review: Standard
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
Aug 22, 2022	Original application	Approved	REMS

Products

6 strengths and forms


Fentanyl CitrateEQ 0.1MG BASE · tablet;buccal, sublingual	Fentanyl Citrate	Discontinued
Fentanyl CitrateEQ 0.2MG BASE · tablet;buccal, sublingual	Fentanyl Citrate	Discontinued
Fentanyl CitrateEQ 0.3MG BASE · tablet;buccal, sublingual	Fentanyl Citrate	Discontinued
Fentanyl CitrateEQ 0.4MG BASE · tablet;buccal, sublingual	Fentanyl Citrate	Discontinued
Fentanyl CitrateEQ 0.6MG BASE · tablet;buccal, sublingual	Fentanyl Citrate	Discontinued
Fentanyl CitrateEQ 0.8MG BASE · tablet;buccal, sublingual	Fentanyl Citrate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Dec 8, 2022	Supplement 1REMS	Approved	None posted
Aug 22, 2022	Original application	Approved	REMS

Identifiers

Application: ANDA 206329
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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