Details for New Drug Application (NDA): 019919
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NDA 019919 describes ROWASA, which is a drug marketed by Mylan Speciality Lp and Meda Pharms and is included in two NDAs. It is available from two suppliers. Additional details are available on the ROWASA profile page.
The generic ingredient in ROWASA is mesalamine. There are twenty-eight drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
The generic ingredient in ROWASA is mesalamine. There are twenty-eight drug master file entries for this compound. Forty 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 |
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| Dosage: | SUPPOSITORY;RECTAL | Strength | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
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