Felodipine

ANDA 200815, held by Ph Health. Felodipine.

First approved: Oct 28, 2011
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
Oct 28, 2011	Original application	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Felodipine2.5MG · tablet, extended release;oral	Felodipine	Discontinued
Felodipine5MG · tablet, extended release;oral	Felodipine	Discontinued
Felodipine10MG · tablet, extended release;oral	Felodipine	Discontinued

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 23, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Oct 28, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 200815
Drugs@FDA: Overview at FDA
Company: PH Health

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters