ANDA 204330, held by Novel Labs Inc. Dextroamphetamine Sulfate.
As of Nov 15, 2026, ANDA 204330 (Dextroamphetamine Sulfate), held by Novel Labs Inc, was first approved by FDA on Mar 16, 2016, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Dextroamphetamine Sulfate Tablets USP are indicated for: 1. Narcolepsy. 2. Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 16, 2016 | Original application | Approved | None posted |
| Dextroamphetamine Sulfate5MG · tablet;oral | Dextroamphetamine Sulfate | Rx |
| Dextroamphetamine Sulfate10MG · tablet;oral | Dextroamphetamine Sulfate | Rx |
| Oct 13, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 25, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 15, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 16, 2016 | Original application | Approved | None posted |
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
