Pregabalin

Manages neuropathic pain associated with diabetic peripheral neuropathy. ANDA 206912, held by Hetero Labs Ltd Iii. Pregabalin.

As of Nov 14, 2026, ANDA 206912 (Pregabalin), held by Hetero Labs Ltd Iii, was first approved by FDA on Oct 8, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 8, 2019
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 capsules are 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
Oct 8, 2019	Original application	Approved	None posted

Products

8 strengths and forms


Pregabalin25MG · capsule;oral	Pregabalin	Rx
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

All 3 submissions, including labeling and manufacturing supplements


Aug 21, 2025	Supplement 12Labeling · Standard review	Approved	None posted
Aug 28, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Oct 8, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 206912
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd Iii

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