Treats Wilson's disease, cystinuria. ANDA 211231, held by Ph Health. Penicillamine.
As of Nov 15, 2026, ANDA 211231 (Penicillamine), held by Ph Health, was first approved by FDA on Dec 23, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS Penicillamine capsules are indicated in the treatment of Wilson's disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that penicillamine capsules are not of value in ankylosing spondylitis. W il son’s Disease — Wilson’s disease (hepatolenticular degeneration) occurs in individuals who have inherited an autosomal recessive defect that leads to an accumulation of copper far in excess of metabolic requirements.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Penicillamine250MG · capsule;oral | Penicillamine | Rx |
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
