FDA.reportPublic FDA data

Application 075028

Type
ANDA
Sponsor
VALEANT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENTOXIFYLLINEPENTOXIFYLLINETABLET, EXTENDED RELEASE;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43353-123PentoxifyllinePentoxifyllineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-123PentoxifyllinePentoxifyllineAphena Pharma Solutions - Tennessee, LLCANDACurrent
68071-4532PentoxifyllinePentoxifyllineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4532PentoxifyllinePentoxifyllineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4532PentoxifyllinePentoxifyllineNuCare Pharmaceuticals,Inc.ANDACurrent
68682-101PentoxifyllinePentoxifyllineOceanside PharmaceuticalsANDACurrent
68682-101PentoxifyllinePentoxifyllineOceanside PharmaceuticalsANDACurrent
68682-101PentoxifyllinePentoxifyllineOceanside PharmaceuticalsANDACurrent
68682-101PentoxifyllinePentoxifyllineOceanside PharmaceuticalsANDACurrent
68682-101PentoxifyllinePentoxifyllineOceanside PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42923ORIG1998-07-20
30734ORIG1998-07-20