Pregabalin

Manages neuropathic pain associated with diabetic peripheral neuropathy. ANDA 91157, held by Sun Pharm. Pregabalin.

As of Nov 13, 2026, ANDA 91157 (Pregabalin), held by Sun Pharm, was first approved by FDA on Nov 29, 2019, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 29, 2019
Supplements approved: 3
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 4 submissions below

Date	Submission	Status	Documents
Nov 29, 2019	Original application	Approved	None posted

Products

8 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Mar 24, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Mar 24, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Mar 24, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Nov 29, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 91157
Drugs@FDA: Overview at FDA
Company: Sun 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