Details for New Drug Application (NDA): 219997
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NDA 219997 describes MESALAMINE, which is a drug marketed by Teva Pharms Usa, Alembic, Alkem Labs Ltd, Amta, Annora Pharma, Aurobindo Pharma Ltd, Difgen Pharms, Mylan, Novast Labs, Sun Pharm, Zydus Pharms, Encube, G And W Labs Inc, Klm Labs Pvt, Novitium Pharma, Padagis Israel, Actavis Mid Atlantic, Amneal, Amring Pharms, Quagen, Rising, Sandoz, Actavis Labs Fl, Sinotherapeutics Inc, and Teva Pharms Inc, and is included in thirty-five NDAs. It is available from thirty-four suppliers. Additional details are available on the MESALAMINE profile page.
The generic ingredient in MESALAMINE is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
The generic ingredient in MESALAMINE is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 219997
| Tradename: | MESALAMINE |
| Applicant: | Difgen Pharms |
| Ingredient: | mesalamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219997
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MESALAMINE | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 219997 | ANDA | Sandoz Inc | 0781-2791 | 0781-2791-64 | 240 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2791-64) |
| MESALAMINE | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 219997 | ANDA | Sandoz Inc | 0781-2793 | 0781-2793-72 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2793-72) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 250MG | ||||
| Approval Date: | Mar 10, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Mar 10, 2026 | TE: | AB | RLD: | No | ||||
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