FDA.reportPublic FDA data

Application 074943

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL240MGNoYes
002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL180MGNoNo
003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-523DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDENORTHSTAR RX LLCANDACurrent
16714-524DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDENORTHSTAR RX LLCANDACurrent
16714-525DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDENORTHSTAR RX LLCANDACurrent
53002-1521DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDERPK Pharmaceuticals, Inc.ANDACurrent
53002-1521DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDERPK Pharmaceuticals, Inc.ANDACurrent
60505-0014DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEApotex Corp.ANDACurrent
60505-0015DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEApotex Corp.ANDACurrent
60505-0016DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEApotex Corp.ANDACurrent
70934-210DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-210DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0266DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0266DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18378ORIG2004-06-02
42904ORIG2003-08-04
8470ORIG1998-08-06