FDA.reportPublic FDA data

Application 064150

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIFAMPINRIFAMPINCAPSULE;ORAL300MGNoNo
002RIFAMPINRIFAMPINCAPSULE;ORAL150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0799RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0799RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0799RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0799RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0799RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0799RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0799RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0799RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0799RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0801RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0801RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0801RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0801RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0801RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0801RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0801RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0801RifampinRifampinEon Labs, Inc.ANDACurrent
0185-0801RifampinRifampinEon Labs, Inc.ANDACurrent
0904-5282RIFAMPINRIFAMPINMajor PharmaceuticalsANDACurrent
0904-5282RIFAMPINRIFAMPINMajor PharmaceuticalsANDACurrent
0904-5282RIFAMPINRIFAMPINMajor PharmaceuticalsANDACurrent
0904-5282RIFAMPINRIFAMPINMajor PharmaceuticalsANDACurrent
21695-527RifampinRifampinRebel Distributors CorpANDACurrent
42806-799RIFAMPINrifampinEPIC PHARMA, LLCANDACurrent
42806-799RIFAMPINrifampinEPIC PHARMA, LLCANDACurrent
42806-801RIFAMPINrifampinEPIC PHARMA, LLCANDACurrent
42806-801RIFAMPINrifampinEPIC PHARMA, LLCANDACurrent
50090-4961RifampinRifampinA-S Medication SolutionsANDACurrent
50090-4961RifampinRifampinA-S Medication SolutionsANDACurrent
51079-890RifampinRifampinMylan Institutional Inc.ANDACurrent
53002-6430RifampinRifampinRPK Pharmaceuticals, Inc.ANDACurrent
53002-6430RifampinRifampinRPK Pharmaceuticals, Inc.ANDACurrent
55154-5351RifampinRifampinCardinal HealthANDACurrent
63629-4042RifampinRifampinBryant Ranch PrepackANDACurrent
63629-4042RifampinRifampinBryant Ranch PrepackANDACurrent
63629-4042RifampinRifampinBryant Ranch PrepackANDACurrent
63629-4042RifampinRifampinBryant Ranch PrepackANDACurrent
63739-415RifampinRifampinMcKesson Corporation dba SKY PackagingANDACurrent
63739-415RifampinRifampinMcKesson Corporation dba SKY PackagingANDACurrent
63739-415RifampinRifampinMcKesson Corporation dba SKY PackagingANDACurrent
76420-060RifampinRifampinAsclemed USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42785ORIG2011-03-10
8352ORIG2011-03-10