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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010721
Company: CASPER PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANTIVERT MECLIZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription AA Yes No
ANTIVERT MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription AA Yes No
ANTIVERT MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE;ORAL Prescription AA Yes No
ANTIVERT MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription AA Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/28/2019 SUPPL-63 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010721s063lbl.pdf
12/12/2018 SUPPL-62 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/010721Orig1s062_CartonLbl.pdf
12/12/2018 SUPPL-62 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017210s062lbl.pdf
04/13/2018 SUPPL-61 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/010721s061lbl.pdf
10/23/2012 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/010721s058lbl.pdf
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