Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203286
Company: ZYDUS PHARMS USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MESALAMINE MESALAMINE 800MG 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
07/21/2017 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203286Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/2018 SUPPL-2 Labeling-Proprietary Name Change

Label is not available on this site.

06/26/2018 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

MESALAMINE

TABLET, DELAYED RELEASE;ORAL; 800MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ASACOL HD MESALAMINE 800MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 021830 APIL
MESALAMINE MESALAMINE 800MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 203286 ZYDUS PHARMS USA INC

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