Treats symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic…. ANDA 205304, held by Edenbridge Pharms. Carbidopa.
As of Nov 15, 2026, ANDA 205304 (Carbidopa), held by Edenbridge Pharms, was first approved by FDA on Feb 17, 2016, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Carbidopa tablets are indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. Carbidopa tablets are for use with carbidopa-levodopa in patients for whom the dosage of carbidopa-levodopa tablets provides less than adequate daily dosage (usually 70 mg daily) of carbidopa.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 17, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Carbidopa25MG · tablet;oral | Carbidopa | Rx |
| Apr 9, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 17, 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
