Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019919
Company: MEDA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROWASA MESALAMINE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUPPOSITORY;RECTAL Discontinued None Yes No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
12/18/1990 ORIG-1 Approval Type 3 - New Dosage Form 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
10/01/2001 SUPPL-4 Labeling

Label is not available on this site.

08/08/1997 SUPPL-2 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019919a_s002.pdf
02/19/1992 SUPPL-1 Labeling

Label is not available on this site.

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