Details for New Drug Application (NDA): 019919
✉ Email this page to a colleague
The generic ingredient in ROWASA is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 019919
Tradename: | ROWASA |
Applicant: | Meda Pharms |
Ingredient: | mesalamine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 019919
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUPPOSITORY;RECTAL | Strength | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 18, 1990 | TE: | RLD: | Yes |
Complete Access Available with Subscription