Relgaabi

Manages postherpetic neuralgia. ANDA 204989, held by Sciegen Pharms. Gabapentin.

As of Nov 14, 2026, ANDA 204989 (Relgaabi), held by Sciegen Pharms, was first approved by FDA on Feb 18, 2016, with 9 approved supplements and 0 published complete response letters.

First approved: Feb 18, 2016
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Gabapentin is indicated for:

Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin is indicated for:
Postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Feb 18, 2016	Original application	Approved	Letter

Products

4 strengths and forms


Relgaabi100MG · capsule;oral	Gabapentin	Rx
Relgaabi300MG · capsule;oral	Gabapentin	Rx
Relgaabi400MG · capsule;oral	Gabapentin	Rx
Relgaabi200MG · capsule;oral	Gabapentin	Rx

All 10 submissions, including labeling and manufacturing supplements


Feb 17, 2026	Supplement 40Labeling · Standard review	Approved	None posted
Dec 31, 2024	Supplement 20Labeling · Standard review	Approved	None posted
Dec 31, 2024	Supplement 32Labeling · Standard review	Approved	None posted
Dec 31, 2024	Supplement 37Labeling · Standard review	Approved	None posted
Sep 29, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Sep 29, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Sep 29, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Sep 29, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Sep 29, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Feb 18, 2016	Original application	Approved	Letter

Identifiers

Application: ANDA 204989
Drugs@FDA: Overview at FDA
Company: ScieGen 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