FDA.reportPublic FDA data

Application 063009

Type
ANDA
Sponsor
ZYDUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDECAPSULE;ORALEQ 100MG BASENoYes
002MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDECAPSULE;ORALEQ 75MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-317Minocycline hydrochlorideMinocycline hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-317Minocycline hydrochlorideMinocycline hydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-317Minocycline hydrochlorideMinocycline hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-318Minocycline hydrochlorideMinocycline hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-318Minocycline hydrochlorideMinocycline hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-318Minocycline hydrochlorideMinocycline hydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
70518-2943Minocycline hydrochlorideMinocycline hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2943Minocycline hydrochlorideMinocycline hydrochlorideREMEDYREPACK INC.ANDACurrent
70771-1427Minocycline hydrochlorideMinocycline hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1427Minocycline hydrochlorideMinocycline hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1427Minocycline hydrochlorideMinocycline hydrochlorideZydus Lifesciences LimitedANDACurrent
70771-1427Minocycline hydrochlorideMinocycline hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1428Minocycline hydrochlorideMinocycline hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1428Minocycline hydrochlorideMinocycline hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1428Minocycline hydrochlorideMinocycline hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1428Minocycline hydrochlorideMinocycline hydrochlorideZydus Lifesciences LimitedANDACurrent
70771-1428Minocycline hydrochlorideMinocycline hydrochlorideCadila Healthcare LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8347SUPPL2014-02-24
18316SUPPL2014-02-21