Pregabalin

Manages neuropathic pain associated with diabetic peripheral neuropathy. ANDA 212988, held by Pharmazone. Pregabalin.

As of Nov 13, 2026, ANDA 212988 (Pregabalin), held by Pharmazone, was first approved by FDA on Mar 8, 2022, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 8, 2022
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
Mar 8, 2022	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


Mar 30, 2026	Supplement 3Labeling · Standard review	Approved	None posted
Jul 21, 2023	Supplement 1Manufacturing	Approved	None posted
Mar 8, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 212988
Drugs@FDA: Overview at FDA
Company: Pharmazone

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