FDA.reportPublic FDA data

Application 204453

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-9208Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9208Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9209Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9209Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9210Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9210Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9211Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9211Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9212Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9212Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9213Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9213Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9214Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9214Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9215Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
63629-9215Minocycline HydrochlorideMinocycline HydrochlorideBryant Ranch PrepackANDACurrent
67877-436Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-436Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-437Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-437Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-437Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-438Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-438Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-438Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-576Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-576Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-576Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-577Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-577Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-577Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-578Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-578Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-578Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-643Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-643Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-643Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-644Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-644Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent
67877-644Minocycline HydrochlorideMinocycline HydrochlorideAscend Laboratories, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53620ORIG2018-04-05