Treats symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic…. ANDA 204763, held by Novel Labs Inc. Carbidopa.
As of Nov 14, 2026, ANDA 204763 (Carbidopa), held by Novel Labs Inc, was first approved by FDA on Oct 20, 2017, with 0 approved supplements 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 is for use with carbidopa-levodopa in patients for whom the dosage of carbidopa-levodopa provides less than adequate daily dosage (usually 70 mg daily) of carbidopa. Carbidopa is for use with levodopa in the occasional patient whose dosage requirement of carbidopa and levodopa necessitates separate titration of each medication.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 20, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Carbidopa25MG · tablet;oral | Carbidopa | 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
