Details for New Drug Application (NDA): 215067
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NDA 215067 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 thirty NDAs. It is available from thirty 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 215067
| Tradename: | MESALAMINE |
| Applicant: | Amneal |
| Ingredient: | mesalamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215067
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MESALAMINE | mesalamine | TABLET, DELAYED RELEASE;ORAL | 215067 | ANDA | Amneal Pharmaceuticals LLC | 65162-360 | 65162-360-18 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-360-18) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 800MG | ||||
| Approval Date: | Feb 18, 2025 | TE: | AB | RLD: | No | ||||
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