Carbidopa

ANDA 203261, held by Ani Pharms. Carbidopa.

As of Nov 14, 2026, ANDA 203261 (Carbidopa), held by Ani Pharms, was first approved by FDA on Mar 10, 2014, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 10, 2014
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Mar 10, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Carbidopa25MG · tablet;oral	Carbidopa	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Apr 19, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Mar 10, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 203261
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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