NDA 19152, held by Pfizer. Verapamil Hydrochloride.
As of Nov 13, 2026, NDA 19152 (Calan Sr), held by Pfizer, was first approved by FDA on Dec 16, 1986, with 37 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 15, 1989 | Supplement 9Efficacy (new indication or use) | Approved | None posted |
| Dec 16, 1986 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Calan Sr240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Verapamil Hydrochloride | DiscontinuedReference drug |
| Calan Sr180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Verapamil Hydrochloride | DiscontinuedReference drug |
| Calan Sr120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Verapamil Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2020 | Supplement 45Manufacturing | Approved | |
| Oct 28, 2019 | Supplement 44Labeling · Standard review | Approved | |
| Sep 14, 2017 | Supplement 41Labeling · Standard review | Approved | |
| Aug 24, 2016 | Supplement 39Labeling · Standard review | Approved | |
| Oct 28, 2013 | Supplement 38Labeling · Standard review | Approved | |
| Jan 10, 2013 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Dec 1, 2011 | Supplement 35Labeling | Approved | |
| Mar 31, 2010 | Supplement 33Labeling | Approved | |
| Jul 1, 2009 | Supplement 32Labeling · Standard review | Approved | |
| Nov 26, 2002 | Supplement 30Manufacturing · Standard review | Approved | |
| Sep 28, 2001 | Supplement 26Labeling · Standard review | Approved | None posted |
| Feb 14, 2001 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Feb 12, 2001 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jul 14, 2000 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Dec 11, 1998 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jan 13, 1998 | Supplement 23Labeling · Standard review | Approved | None posted |
| May 16, 1997 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Mar 17, 1995 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jul 28, 1994 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Nov 5, 1993 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Sep 23, 1992 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Sep 3, 1992 | Supplement 17Labeling | Approved | None posted |
| May 4, 1992 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Mar 6, 1991 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 6, 1991 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jan 19, 1990 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Dec 15, 1989 | Supplement 9Efficacy (new indication or use) | Approved | None posted |
| Aug 8, 1989 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1989 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 17, 1989 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1989 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1988 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1988 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1988 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1988 | Supplement 8Labeling | Approved | None posted |
| Jul 20, 1988 | Supplement 5Labeling | Approved | None posted |
| Sep 24, 1987 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 16, 1986 | Original applicationNew dosage form · Standard review | 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
