Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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 Discontinued None No No
ANTIVERT MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Discontinued None No No
ANTIVERT MECLIZINE HYDROCHLORIDE 25MG TABLET, CHEWABLE;ORAL Discontinued None No No
ANTIVERT MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Discontinued None No 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
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
10/23/2012 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/010721s058lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English