Details for New Drug Application (NDA): 213191
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NDA 213191 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 213191
| Tradename: | MESALAMINE |
| Applicant: | Teva Pharms Inc |
| Ingredient: | mesalamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213191
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MESALAMINE | mesalamine | TABLET, DELAYED RELEASE;ORAL | 213191 | ANDA | Teva Pharmaceuticals, Inc. | 0480-7750 | 0480-7750-80 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (0480-7750-80) |
| MESALAMINE | mesalamine | TABLET, DELAYED RELEASE;ORAL | 213191 | ANDA | AvKARE | 42291-489 | 42291-489-18 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-489-18) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 800MG | ||||
| Approval Date: | Aug 22, 2024 | TE: | AB | RLD: | No | ||||
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