Pregabalin

Manages neuropathic pain associated with diabetic peripheral neuropathy. ANDA 214322, held by Tris Pharma Inc. Pregabalin.

As of Nov 13, 2026, ANDA 214322 (Pregabalin), held by Tris Pharma Inc, was first approved by FDA on Jul 15, 2021, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 15, 2021
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pregabalin capsules are indicated for:

Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury Pregabalin is indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
Postherpetic neuralgia (PHN)
Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
Fibromyalgia
Neuropathic pain associated with spinal cord injury

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 15, 2021	Original application	Approved	None posted

Products

8 strengths and forms


Pregabalin50MG · capsule;oral	Pregabalin	Rx
Pregabalin75MG · capsule;oral	Pregabalin	Rx
Pregabalin100MG · capsule;oral	Pregabalin	Rx
Pregabalin150MG · capsule;oral	Pregabalin	Rx
Pregabalin200MG · capsule;oral	Pregabalin	Rx
Pregabalin225MG · capsule;oral	Pregabalin	Rx
Pregabalin300MG · capsule;oral	Pregabalin	Rx
Pregabalin25MG · capsule;oral	Pregabalin	Rx

All 3 submissions, including labeling and manufacturing supplements


Feb 2, 2026	Supplement 6Labeling · Standard review	Approved	None posted
Mar 24, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Jul 15, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 214322
Drugs@FDA: Overview at FDA
Company: Tris Pharma

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