Details for New Drug Application (NDA): 214477
✉ Email this page to a colleague
NDA 214477 describes MESALAMINE, which is a drug marketed by Teva Pharms Usa, Alembic, Alkem Labs Ltd, Amta, Aurobindo Pharma Ltd, Mylan, Novast Labs, Sun Pharm, Zydus Pharms, Encube, G And W Labs Inc, Padagis Israel, Actavis Mid Atlantic, Amneal, Amring Pharms, Annora Pharma, Rising, Sandoz, Actavis Labs Fl, Sinotherapeutics Inc, and Teva Pharms Inc, and is included in twenty-nine NDAs. It is available from twenty-nine 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 214477
| Tradename: | MESALAMINE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | mesalamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214477
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MESALAMINE | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 214477 | ANDA | Aurobindo Pharma Limited | 59651-397 | 59651-397-08 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-397-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 375MG | ||||
| Approval Date: | Mar 31, 2023 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
