FDA.reportPublic FDA data

Application 078745

Type
ANDA
Sponsor
CHARTWELL MOLECULAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAMIPRILRAMIPRILCAPSULE;ORAL1.25MGNoNo
002RAMIPRILRAMIPRILCAPSULE;ORAL2.5MGNoNo
003RAMIPRILRAMIPRILCAPSULE;ORAL5MGNoNo
004RAMIPRILRAMIPRILCAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-271RamiprilRamiprilCamber PharmaceuticalsANDACurrent
31722-272RamiprilRamiprilCamber PharmaceuticalsANDACurrent
31722-273RamiprilRamiprilCamber PharmaceuticalsANDACurrent
31722-274RamiprilRamiprilCamber PharmaceuticalsANDACurrent
42291-692RamiprilRamiprilAvKARE, Inc.ANDACurrent
62135-271RamiprilRamiprilChartwell RX, LLC.ANDACurrent
62135-271RamiprilRamiprilChartwell RX, LLC.ANDACurrent
62135-272RamiprilRamiprilChartwell RX, LLC.ANDACurrent
62135-272RamiprilRamiprilChartwell RX, LLC.ANDACurrent
62135-273RamiprilRamiprilChartwell RX, LLC.ANDACurrent
62135-273RamiprilRamiprilChartwell RX, LLC.ANDACurrent
62135-274RamiprilRamiprilChartwell RX, LLC.ANDACurrent
62135-274RamiprilRamiprilChartwell RX, LLC.ANDACurrent
76282-271RamiprilRamiprilExelan Pharmaceuticals, Inc.ANDACurrent
76282-272RamiprilRamiprilExelan Pharmaceuticals, Inc.ANDACurrent
76282-273RamiprilRamiprilExelan Pharmaceuticals, Inc.ANDACurrent
76282-274RamiprilRamiprilExelan Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44395ORIG2008-07-01