FDA.reportPublic FDA data

Application 202261

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 45MG BASENoNo
002MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 65MG BASENoNo
003MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 90MG BASENoNo
004MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 115MG BASENoNo
005MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 135MG BASENoNo
006MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 80MG BASENoNo
007MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 105MG BASENoNo
008MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 55MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-102Minocycline HydrochlorideMinocycline HydrochlorideNorthStar Rx LLCANDACurrent
16714-103Minocycline HydrochlorideMinocycline HydrochlorideNorthStar Rx LLCANDACurrent
16714-104Minocycline HydrochlorideMinocycline HydrochlorideNorthStar Rx LLCANDACurrent
16714-105Minocycline HydrochlorideMinocycline HydrochlorideNorthStar Rx LLCANDACurrent
16714-106Minocycline HydrochlorideMinocycline HydrochlorideNorthStar Rx LLCANDACurrent
16714-107Minocycline HydrochlorideMinocycline HydrochlorideNorthStar Rx LLCANDACurrent
16714-108Minocycline HydrochlorideMinocycline HydrochlorideNorthStar Rx LLCANDACurrent
16714-109Minocycline HydrochlorideMinocycline HydrochlorideNorthStar Rx LLCANDACurrent
42546-771Minocycline HydrochlorideMinocycline HydrochloridePruGen PharmaceuticalsANDACurrent
42546-771Minocycline HydrochlorideMinocycline HydrochloridePruGen PharmaceuticalsANDACurrent
42546-771Minocycline HydrochlorideMinocycline HydrochloridePruGen PharmaceuticalsANDACurrent
42546-771Minocycline HydrochlorideMinocycline HydrochloridePruGen PharmaceuticalsANDACurrent
42546-774Minocycline HydrochlorideMinocycline HydrochloridePruGen PharmaceuticalsANDACurrent
42546-774Minocycline HydrochlorideMinocycline HydrochloridePruGen PharmaceuticalsANDACurrent
42546-774Minocycline HydrochlorideMinocycline HydrochloridePruGen PharmaceuticalsANDACurrent
42546-774Minocycline HydrochlorideMinocycline HydrochloridePruGen PharmaceuticalsANDACurrent
42546-777Minocycline HydrochlorideMinocycline HydrochloridePruGen PharmaceuticalsANDACurrent
42546-777Minocycline HydrochlorideMinocycline HydrochloridePruGen PharmaceuticalsANDACurrent
42546-777Minocycline HydrochlorideMinocycline HydrochloridePruGen PharmaceuticalsANDACurrent
42546-777Minocycline HydrochlorideMinocycline HydrochloridePruGen PharmaceuticalsANDACurrent
65862-554Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-554Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-554Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-554Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-555Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-555Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-555Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-555Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-556Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-556Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-556Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-556Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-557Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-557Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-557Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-557Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-558Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-558Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-558Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-558Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-883Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-883Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-883Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-884Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-884Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-884Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-884Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-885Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-885Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-885Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-885Minocycline HydrochlorideMinocycline HydrochlorideAurobindo Pharma LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55945ORIG2018-10-15