Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202720
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription AB No No
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG 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
10/30/2014 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/13/2015 SUPPL-1 REMS-Proposal

Label is not available on this site.

MYCOPHENOLIC ACID

TABLET, DELAYED RELEASE;ORAL; 180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 202555 ACCORD HLTHCARE
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091558 APOTEX INC
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091248 MYLAN PHARMS INC
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 202720 TEVA PHARMS USA
MYFORTIC MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050791 NOVARTIS

TABLET, DELAYED RELEASE;ORAL; 360MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 202555 ACCORD HLTHCARE
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091558 APOTEX INC
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091248 MYLAN PHARMS INC
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 202720 TEVA PHARMS USA
MYFORTIC MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050791 NOVARTIS

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