Pregabalin

Manages neuropathic pain associated with diabetic peripheral neuropathy. ANDA 213423, held by Creekwood Pharms. Pregabalin.

As of Nov 14, 2026, ANDA 213423 (Pregabalin), held by Creekwood Pharms, was first approved by FDA on Mar 23, 2020, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 23, 2020
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pregabalin capsule is 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 4 submissions below

Date	Submission	Status	Documents
Mar 23, 2020	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 4 submissions, including labeling and manufacturing supplements


Oct 1, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Oct 1, 2025	Supplement 6Labeling · Standard review	Approved	None posted
Oct 1, 2025	Supplement 7Labeling · Standard review	Approved	None posted
Mar 23, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 213423
Drugs@FDA: Overview at FDA
Company: Creekwood Pharmaceuticals

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