FDA.reportPublic FDA data

Application 019152

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CALAN SRVERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL240MGYesYes
002CALAN SRVERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL180MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003CALAN SRVERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL120MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-1891CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-1891CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1891CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-1891CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-1891CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1891CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-1891CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-1891CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1891CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1891CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-1891CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1901CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1901CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-1901CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-1901CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1901CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-1901CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-1901CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1901CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1901CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-1901CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-1901CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1911CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1911CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1911CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-1911CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1911CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-1911CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1911CALAN SRverapamil hydrochlorideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-2712CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-2712CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-2712CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-2818CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-2818CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-2818CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-2818CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-2818CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-2818CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-2818CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-2924CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-2924CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-2924CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-2924CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
0025-2924CALAN SRverapamil hydrochloridePfizer Laboratories Div Pfizer IncNDACurrent
53808-0324Verapamil HydrochlorideVerapamil HydrochlorideState of Florida DOH Central PharmacyNDACurrent
53808-0972Verapamil HydrochlorideVerapamil HydrochlorideState of Florida DOH Central PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66995SUPPL2021-04-07
66818SUPPL2021-03-19
60705SUPPL2019-10-29
60704SUPPL2019-10-29
49798SUPPL2017-09-19
49761SUPPL2017-09-18
47293SUPPL2017-02-23
45233SUPPL2016-08-24
16205SUPPL2013-10-28
11441SUPPL2013-10-28
16204SUPPL2011-12-05
11440SUPPL2011-12-02
11439SUPPL2010-04-04
1238SUPPL2010-04-02
11438SUPPL2009-07-09
1237SUPPL2009-07-08
16203SUPPL2002-11-26