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, 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 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. Forty 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. Forty 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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