FDA.reportPublic FDA data

Application 010721

Type
NDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANTIVERTMECLIZINE HYDROCHLORIDETABLET;ORAL50MGYesNo
004ANTIVERTMECLIZINE HYDROCHLORIDETABLET;ORAL25MGYesNo
005ANTIVERTMECLIZINE HYDROCHLORIDETABLET, CHEWABLE;ORAL25MGYesNo
006ANTIVERTMECLIZINE HYDROCHLORIDETABLET;ORAL12.5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-660Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
16571-660Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
16571-661Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
16571-661Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
16571-662Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
16571-662Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
16571-663Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
16571-663Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55700-912Meclizine HydrochlorideMeclizine HydrochlorideQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
55700-919Meclizine HydrochlorideMeclizine HydrochlorideQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
55700-919Meclizine HydrochlorideMeclizine HydrochlorideQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
60760-661Meclizine HydrochlorideMeclizine HydrochlorideSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
60760-661Meclizine HydrochlorideMeclizine HydrochlorideSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
60760-661Meclizine HydrochlorideMeclizine HydrochlorideSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
60760-661Meclizine HydrochlorideMeclizine HydrochlorideSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
67296-1432Meclizine HydrochlorideMeclizine HydrochlorideRedPharm Drug, Inc.NDA AUTHORIZED GENERICCurrent
68071-2380Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68071-2416Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
70199-002Antivertmeclizine HClCasper Pharma LLCNDACurrent
70199-002Antivertmeclizine HClCasper Pharma LLCNDACurrent
70199-003Antivertmeclizine HClCasper Pharma LLCNDACurrent
70199-003Antivertmeclizine HClCasper Pharma LLCNDACurrent
70199-004Antivertmeclizine hclCasper Pharma LLCNDACurrent
70199-004Antivertmeclizine hclCasper Pharma LLCNDACurrent
70199-018Antivertmeclizine hclCasper Pharma LLCNDACurrent
70199-018Antivertmeclizine hclCasper Pharma LLCNDACurrent
71205-647Meclizine HydrochlorideMeclizine HydrochlorideProficient Rx LPNDA AUTHORIZED GENERICCurrent
71335-1825Meclizine HydrochlorideMeclizine HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1872Meclizine HydrochlorideMeclizine HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
72189-237MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDIRECT RXNDA AUTHORIZED GENERICCurrent
72189-237Meclizine HydrochlorideMeclizine HydrochlorideDirect_RxNDA AUTHORIZED GENERICCurrent
72189-237MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDIRECT RXNDA AUTHORIZED GENERICCurrent
72189-237MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDIRECT RXNDA AUTHORIZED GENERICCurrent
72189-302MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDirectRxNDA AUTHORIZED GENERICCurrent
72189-302MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDirectRxNDA AUTHORIZED GENERICCurrent
74074-003Meclizine HydrochlorideMeclizine HydrochlorideNortic Pharma, LLCNDA AUTHORIZED GENERICCurrent
74074-003Meclizine HydrochlorideMeclizine HydrochlorideNortic Pharma, LLCNDA AUTHORIZED GENERICCurrent
74074-004Meclizine HydrochlorideMeclizine HydrochlorideNortic Pharma, LLCNDA AUTHORIZED GENERICCurrent
74074-004Meclizine HydrochlorideMeclizine HydrochlorideNortic Pharma, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59240SUPPL2019-07-05
59203SUPPL2019-07-01
58931SUPPL2019-06-03
56855SUPPL2018-12-20
56729SUPPL2018-12-13
53694SUPPL2018-04-16
53682SUPPL2018-04-16
33027SUPPL2012-10-24
234SUPPL2012-10-24