Details for New Drug Application (NDA): 216967
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NDA 216967 describes MESALAMINE, which is a drug marketed by Teva Pharms Usa, Alembic, Alkem Labs Ltd, Amta, Annora Pharma, Aurobindo Pharma Ltd, Mylan, Novast Labs, Sun Pharm, Zydus Pharms, Encube, G And W Labs Inc, 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-three 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-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 216967
| Tradename: | MESALAMINE |
| Applicant: | Alembic |
| Ingredient: | mesalamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216967
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MESALAMINE | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 216967 | ANDA | Alembic Pharmaceuticals Limited | 46708-724 | 46708-724-35 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-724-35) |
| MESALAMINE | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 216967 | ANDA | Alembic Pharmaceuticals Limited | 46708-724 | 46708-724-91 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-724-91) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 375MG | ||||
| Approval Date: | Oct 28, 2022 | TE: | AB | RLD: | No | ||||
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