Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205995
Company: ZYDUS PHARMS USA INC
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 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
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 200143 BARR LABS DIV TEVA
ACAMPROSATE CALCIUM ACAMPROSATE CALCIUM 333MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 202229 GLENMARK GENERICS
ACAMPROSATE CALCIUM ACAMPROSATE CALCIUM 333MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 200142 MYLAN PHARMS INC
ACAMPROSATE CALCIUM ACAMPROSATE CALCIUM 333MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 205995 ZYDUS PHARMS USA INC

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