U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205995
Company: ZYDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACAMPROSATE CALCIUM ACAMPROSATE CALCIUM 333MG TABLET, DELAYED RELEASE;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/26/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

ACAMPROSATE CALCIUM

TABLET, DELAYED RELEASE;ORAL; 333MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACAMPROSATE CALCIUM ACAMPROSATE CALCIUM 333MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 200142 MYLAN
ACAMPROSATE CALCIUM ACAMPROSATE CALCIUM 333MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 205995 ZYDUS PHARMS
Back to Top