Adalat Cc

NDA 20198, held by Norwich. Nifedipine.

As of Nov 13, 2026, NDA 20198 (Adalat Cc), held by Norwich, was first approved by FDA on Apr 21, 1993, with 16 approved supplements and 0 published complete response letters.

First approved: Apr 21, 1993
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Apr 21, 1993	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Adalat Cc30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Nifedipine	DiscontinuedReference drug
Adalat Cc60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Nifedipine	DiscontinuedReference drug
Adalat Cc90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Nifedipine	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 17, 2016	Supplement 25Manufacturing · Standard review	Approved	None posted
Mar 9, 2015	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 28, 2011	Supplement 23Labeling	Approved	Letter Label
Mar 3, 2010	Supplement 22Labeling · Standard review	Approved	Letter Label
Apr 1, 2005	Supplement 17Labeling · Standard review	Approved	Letter Label
Apr 13, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 18, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 23, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 29, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 14, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 24, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 14, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 28, 1994	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 7, 1994	Supplement 3Labeling · Standard review	Approved	None posted
Dec 6, 1993	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 23, 1993	Supplement 1Labeling · Standard review	Approved	None posted
Apr 21, 1993	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20198
Drugs@FDA: Overview at FDA
Company: Norwich 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