Treats partial-onset seizures. ANDA 216197, held by Pharmazone. Pregabalin.
As of Nov 13, 2026, ANDA 216197 (Pregabalin), held by Pharmazone, was first approved by FDA on Jul 18, 2022, with 3 approved supplements and 0 published complete response letters.
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 Pregabalin capsules are indicated for:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 18, 2022 | Original application | Approved | None posted |
| 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 |
| Sep 17, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 24, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 24, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 18, 2022 | 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
