Details for New Drug Application (NDA): 208954
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NDA 208954 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 208954
| Tradename: | MESALAMINE |
| Applicant: | Zydus Pharms |
| Ingredient: | mesalamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208954
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MESALAMINE | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 208954 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-452 | 68382-452-19 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-452-19) |
| MESALAMINE | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 208954 | ANDA | Zydus Lifesciences Limited | 70771-1625 | 70771-1625-7 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1625-7) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 375MG | ||||
| Approval Date: | Aug 12, 2021 | TE: | AB | RLD: | No | ||||
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