Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/14/1957 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010721s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/010721Orig1s063ltr.pdf
12/12/2018 SUPPL-62 Labeling-Container/Carton Labels Label (PDF)
Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/010721Orig1s062_CartonLbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017210s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/010721Orig1s062ltr.pdf
04/13/2018 SUPPL-61 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/010721s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/010721Orig1s061ltr.pdf
10/23/2012 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/010721s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/010721Orig1s058ltr.pdf
12/14/1999 SUPPL-54 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/10/1999 SUPPL-53 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/02/1993 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

09/17/1993 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

03/12/1993 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

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

ANTIVERT

TABLET;ORAL; 50MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANTIVERT MECLIZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription Yes AA 010721 CASPER PHARMA LLC

TABLET;ORAL; 25MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANTIVERT MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription Yes AA 010721 CASPER PHARMA LLC
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 201451 AMNEAL PHARMS
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 200294 EPIC PHARMA LLC
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 205136 INDICUS PHARMA
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 040659 JUBILANT CADISTA
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 202640 MYLAN PHARMS INC
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 087128 PAR PHARM
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 084092 SANDOZ

TABLET, CHEWABLE;ORAL; 25MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANTIVERT MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE;ORAL Prescription Yes AA 010721 CASPER PHARMA LLC

TABLET;ORAL; 12.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANTIVERT MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription Yes AA 010721 CASPER PHARMA LLC
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 201451 AMNEAL PHARMS
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 200294 EPIC PHARMA LLC
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 205136 INDICUS PHARMA
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 040659 JUBILANT CADISTA
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 202640 MYLAN PHARMS INC
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 087127 PAR PHARM
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 084843 SANDOZ

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