Details for New Drug Application (NDA): 203817
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The generic ingredient in MESALAMINE is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 203817
Tradename: | MESALAMINE |
Applicant: | Actavis Labs Fl |
Ingredient: | mesalamine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 203817
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MESALAMINE | mesalamine | TABLET, DELAYED RELEASE;ORAL | 203817 | ANDA | Actavis Pharma, Inc. | 0591-2245 | 0591-2245-22 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-2245-22) |
MESALAMINE | mesalamine | TABLET, DELAYED RELEASE;ORAL | 203817 | ANDA | Bryant Ranch Prepack | 72162-2231 | 72162-2231-2 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2231-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 1.2GM | ||||
Approval Date: | Mar 23, 2018 | TE: | AB | RLD: | No |
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